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U.S. Department of Health and Human Services

Enforcement Report - Week of September 23, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary Co Pro (P) BAL R850-TY250 PEL, 0.3125% Tylan W/O 853598 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Sick Pen Feed W/O 853573, 853571 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Moffatt Calf Ration W/O 853196 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Jerry Helmers Cattle Mix, 0.2775 % Rumensin W/O 853065 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Cracked Corn W/O 853589 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Nelson Protein W/O 853593 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary Horizon Beef BAL. A R1440, 0.8 % Rumensin W/O 853965 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary HB BAL. R 1440 Amaize, 0.8 % Rumensin W/O 853897 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Veterinary FS Calf Aureo, 0.665 % Aureomycin 100 0.075 % Bovatec W/O 853595 Class II Cattle feed was manufactured using a load of rendered animal fat which was not of sufficient grade to be used in ruminant feed. Farmers Cooperative Society
Biologics Red Blood Cells W035414074950, W035414074942, W035414047975 Class III Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced W035414071080, W035414074876, W035414062403, W035414068416, W035414074882, W035414074887 Class III Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W035414075315 (2 units), W035414075317 (2 units), W035414075269 (2 units), W035414075288, W035414047982, W035414062421 (2 units), W035414062428, W035414074956, W035414047985 (2 units), W035414071057, W035414071146, W035414062406, W035414074872, W035414074883 Class III Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W035414074930 (4 units) Class III Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W035414047993 (2 units), W035414075329 (2 units), W035414075334 (2 units), W035414075350, W035414075265, W035414075266, W035414075276, W035414075280 (2 units), W035414075288, W035414047984 (2 units), W035414047990, W035414062415, W035414074953, W035414074956, W035414074972, W035414071081, W035414071146, W035414074928, W035414074932 (2 units), W035414074871 (2 units) Class III Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells (Apheresis) W035414047868, W035414047781, W035414047759, W035414047724, W035414060830, W035414060830, W035414060858, W035414060858, W035414047572, W035414047576, W035414047550, W035414047536 Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W035414060829 Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells W035414074831, W035414073951, W035414073898, W035414070404, W035414070808, W035414068237, W035414068224, W035414068196, W035414047740, W035414047448, W035414060214, W035414065154, W035414065145, W035414062055, W035414060838, W035414063264, W035414059193, W035414059203, W035414064049, W035414060481, W035414061594, W035414061593, W035414061831, W035414057814, W035414047307, W035414057678, W035414044453, W035414060307, W035414058863, W035414059114, W035414049522, W035414059126, W035414051743, W035414058465, W035414058466, W035414058475, W035414059062, W035414059075, W035414060251, W035414061520, W035414061534, W035414047528, W035414059494, W035414047508, W035414044357, W035414059018 Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced W035414063566, W035414074812, W035414073873, W035414073943, W035414073966, W035414073874, W035414073965, W035414073953, W035414073867, W035414073881, W035414069105, W035414069089, W035414069054, W035414067386, W035414072747, W035414073789, W035414047876, W035414073761, W035414067404, W035414072678, W035414072684, W035414072726, W035414072686, W035414057233, W035414057205, W035414067367, W035414072565, W035414072625, W035414072514, W035414062326, W035414070962, W035414070960, W035414070930, W035414070324, W035414070921, W035414062308, W035414070914, W035414070380, W035414070369, W035414070903, W035414070347, W035414070329, W035414064838, W035414064841, W035414062274, W035414067116, W035414070780, W035414070767, W035414070765, W035414064751,  ...
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Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W035414047936, W035414047930, W035414047930, W035414074000, W035414074759, W035414074759, W035414073944, W035414047894, W035414062354, W035414073840, W035414062345, W035414062347, W035414047862, W035414047862, W035414072690, W035414072720, W035414072630, W035414072635, W035414047849, W035414047849, W035414047854, W035414072568, W035414072515, W035414072523, W035414072527, W035414072551, W035414072551, W035414070941, W035414070970, W035414070972, W035414047815, W035414062300, W035414070908, W035414064863, W035414064863, W035414064883, W035414062285, W035414070822, W035414070840, W035414070856, W035414047800, W035414047800, W035414062273, W035414062273, W035414070784, W035414070784, W035414069994, W035414069994, W035414047497, W035414047781,  ...
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Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated W035414073957, W035414072576, W035414072601, W035414072626, W035414072511, W035414047830, W035414047830, W035414047830, W035414047830, W035414070948, W035414070973, W035414070439, W035414070947, W035414070984, W035414070390, W035414047810, W035414064928, W035414064915, W035414061254, W035414066154, W035414057950, W035414069917, W035414067617, W035414069891, W035414067979, W035414064728, W035414066298, W035414066298, W035414066298, W035414066298, W035414068210, W035414068145, W035414068146, W035414066287, W035414061249, W035414068099, W035414066074, W035414061998, W035414061995, W035414064318, W035414064251, W035414047657, W035414065654, W035414060147, W035414065631, W035414065143, W035414061025, W035414062226, W035414063108, W035414065531,  ...
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Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Red Blood Cells Leukocytes Reduced Irradiated Washed W035414068098 Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W035414074817, W035414074817, W035414062389, W035414074825, W035414074823, W035414074782, W035414074786, W035414074785, W035414074775, W035414074775, W035414047941, W035414047941, W035414047936, W035414074802, W035414074802, W035414047933, W035414047933, W035414047933, W035414073985, W035414073999, W035414074000, W035414047899, W035414047899, W035414047903, W035414047908, W035414062369, W035414062369, W035414073860, W035414073861, W035414073944, W035414073954, W035414047894, W035414062354, W035414073796, W035414073833, W035414047858, W035414047858, W035414047858, W035414047859, W035414047859, W035414047860, W035414047860, W035414047868, W035414072690, W035414072720, W035414072630, W035414072631, W035414072635, W035414072652, W035414072652,  ...
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Class II Blood products, which were incorrectly tested for CMV, were distributed. Community Blood Center
Veterinary ADM Alliance Nutrition Super Stressfighter 10 - 51797AWM, Medicated packaged in plain paper bag Net Weight 50 lb (22.67 kg). The responsible name on the label is ADM Alliance Nutrition Quincy, IL. lots: 1WS35414 and 2WS36414 Class III Product may contain elevated levels of chlortetracycline and sulfamethazine. ADM Alliance Nutrition, Inc.
Veterinary -Cisapride 10mg Chicken Tablets -Cisapride 2.5mg capsule -Cisapride 2.5mg Chicken Tablets -Cisapride 2mg capsules -Cisapride 5mg Chicken Tablets Veterinary non-sterile formulation Discard Date: 04/14/2015, 04/26/2015, 04/27/2015, 05/16/2015, 06/13/2015, 06/30/2015 Class II South Coast Specialty Compounding, Inc. dba Park Compounding is recalling Cisapride due to the manufacturer of the active pharmaceutical ingredient(API), Attix Pharmaceuticals, recalling because of the products potentially being contaminated with penicillin. South Coast Specialty Compounding, Inc.
Drugs 5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05012015@19, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Acetyl-L-Carnitine 250 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@40, 8/2/2015; 03202015@17, 6/18/2015; 04132015@58, 7/12/2015; 04212015@5, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Acetyl-L-Carnitine 500 mg/ml, Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@45, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Acetylcysteine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@39, 6/8/2015; 04212015@3, 5/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Alprostadil 10 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12052014@40, 6/3/2015; 12182014@71, 6/16/2015; 01022015@12, 7/1/2015; 02112015@56, 8/10/2015; 02132015@47, 8/12/2015; 03062015@26, 9/2/2015; 03312015@23, 9/27/2015; 04162015@2, 10/13/2015; 05012015@26, 10/28/2015; 05072015@15, 11/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Alprostadil 100 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12012014@41, 5/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Alprostadil 20 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12172014@7, 6/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Alprostadil 40 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01082015@34,7/7/2015; 12162014@46, 6/14/2015; 02032015@98, 8/2/2015; 02112015@79, 8/10/2015, 02192015@15, 8/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Alprostadil 50 mcg/ml Injection, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02032015@24, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@36, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Ascorbic Acid 500 mg/ml Injectable Vial, Sterile Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@1, 8/3/2015; 03112015@4, 6/9/2015; 03122015@32, 6/10/2015; 03122015@90, 6/10/2015; 03232015@6, 6/21/2015; 03272015@38, 6/25/2015; 04072015@21, 7/6/2015; 05112015@75, 8/9/2015; 04222015@9, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Ascorbic Acid 1.25% Glutathione 1.25% DMSO 6.25% Ophthalmic Solution, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03032015@24, 6/1/2015; 03312015@79, 6/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs B-Complex Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02192015@21, 5/20/2015; 03032015@3, 6/1/2015; 02242015@37, 5/25/2015; 03122015@27, 6/10/2015; 03182015@48, 6/16/2015; 03272015@14, 6/25/2015; 04072015@16, 7/6/2015, 04072015@18, 7/6/2015, 04202015@80, 7/19/2015, 04222015@85, 7/21/2015; 05072015@25, 8/5/2015; 04272015@74, 7/26/2015; 04272015@81, 7/26/2015; 04292015@98, 7/28/2015; 05012015@17, 7/30/2015; 05042015@45, 8/2/2015; 02202015@47, 5/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Baclofen 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04272015@23, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Biotin10 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, the Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@46, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Brompheniramine Maleate 20 mg/ml Injectable, Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02192015@51, 5/20/2015; 04162015@14, 7/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Bupivacaine 40 mg/ml +Baclofen 130 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@27, 5/24/2015; 3182015@46, 6/16/2015; 04242015@45, 6/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Bupivacaine 15 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@3, 6/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cholecalciferol 50,000 IU/ml Injectable, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@26, 6/18/2015; 04282015@1, 7/27/2015; 05042015@53, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cholecalciferol 100,000 IU /ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04272015@82, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cholecalciferol 500,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04102015@10, 7/9/2015; 04162015@41, 7/15/2015; 04092015@21, 7/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cholecalciferol 600,000 IU/ml Injectable, ml Vial, Sterile, Refrigerate, The Compounding Pharmac of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03102015@17, 6/8/2015; 03032015@14, 6/1/2015; 03272015@1, 6/25/2015; 04292015@79, 7/28/2015, 04282015@51, 7/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Clotrimazole 2% Otic Suspension, ml, Sterile, Room Temperature, Shake Well, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05012015@13, 5/31/2015, 05012015@16, 5/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Collagenase 250 units/ml, Sterile, Multi-Dose Vial, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05112015@16, 8/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@47, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 05062015@2, 8/4/2015; 03182015@9, 6/16/2015; 03242015@9, 6/22/2015; 03312015@72, 6/29/2015; 04152015@12, 7/14/2015; 04152015@13, 7/14/2015; 05052015@93, 8/3/2015; 05012015@35, 7/30/2015; 05072015@10, 8/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cyanocobalamin 10 mg Pellet, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03042015@33, 8/31/2015; 03312015@29, 9/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cyanocobalamin 1,000 mcg/ml + B-Complex 100 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04232015@35, 7/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@24, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@83, 7/19/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@25, 6/10/2015; 03202015@31, 6/18/2015; 03172015@42, 6/15/2015; 03232015@5, 6/21/2015; 04162015@15, 7/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04222015@67, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12082014@56, 6/6/2015; 01222015@28, 7/21/2015; 01062015@73, 7/5/2015; 03022015@55, 8/29/2015; 03242015@94, 9/20/2015; 04222015@32, 10/19/2015; 04222015@47, 10/19/2015; 04222015@49, 10/19/2015; 04302015@54, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01122015@36, 7/11/2015; 04022015@40, 9/29/2015; 05072015@56, 11/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01082015@8, 7/7/2015; 12052014@62, 6/3/2015; 02242015@10, 8/23/2015; 02122015@29, 7/1/2015; 03032015@19, 8/30/2015; 04232015@13, 10/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 11262014@20, 5/25/2015; 01152015@27, 7/14/2015; 02232015@21, 8/22/2015; 02242015@23, 8/23/2015; 05052015@68, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12112014@4, 6/9/2015; 02102015@18, 8/9/2015; 03022015@59, 8/29/2015; 03242015@96, 9/20/2015; 04292015@16, 10/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12082014@58, 6/6/2015; 02032015@42, 7/1/2015; 02272015@28, 8/26/2015; 03242015@97, 9/20/2015; 05052015@62, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 02242015@1, 8/23/2015; 05042015@29, 10/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 12012014@59, 5/30/2015; 01122015@34, 7/11/2015; 02102015@42, 7/1/2015; 03162015@12, 9/12/2015; 04282015@59, 10/25/2015; 05052015@65, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 03112015@11, 9/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 4 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 12182014@21, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 50 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 11212014@11, 5/20/2015; 02092015@42, 8/8/2015; 02252015@76, 7/1/2015; 04072015@35, 10/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 11212014@13, 5/20/2015; 12182014@35, 6/16/2015; 02202015@1, 8/19/2015; 03022015@48, 8/29/2015; 03172015@33, 9/13/2015; 04232015@24, 10/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 03182015@14, 9/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@48, 9/8/2015; 04212015@20, 10/18/2015; 05052015@37, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol Valerate 20 mg/ml Injectable ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 11262014@56, 5/25/2015; 01262015@16, 7/25/2015; 01302015@51, 7/29/2015; 03272015@41, 9/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04302015@35, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 10,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04062015@14, 7/5/2015; 05012015@48, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@27, 5/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@16, 6/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN All lots distributed between November 2014 and May 2015; 04062015@12, 7/5/2015; 04062015@35, 7/5/2015; 05012015@50, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@10, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 4,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@85, 5/31/2015; 03202015@76, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 7,000 mcg/ml + Bupivacaine 6 mg/ml + Clonidine 40 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@51, 5/20/2015; 04222015@22, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 8,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@70, 6/18/2015; 03242015@103, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@14, 5/26/2015; 04012015@2, 6/30/2015; 04272015@30, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@2, 5/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@71, 5/20/2015; 04272015@31, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@3, 5/31/2015; 03202015@54, 6/18/2015; 04172015@34, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 2,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@1, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@30, 6/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 2,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@2, 6/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 5,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@29, 6/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 5,000 mcg/ml + Baclofen 250 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04032015@30, 7/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 5,000 mcg/ml, + Bupivacaine 15 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@73, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 5,000 mcg/ml + Clonidine 3,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@36m, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@24, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 7,500 mcg/ml, + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@13, 6/7/2015; 04032015@25, 7/2/2015; 05012015@47, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 8,000 mcg/ml, + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@103, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Folic Acid 5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04222015@69, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Glutathione 200 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@78, 6/14/2015; 03262015@42, 6/24/2015; 04202015@82, 7/19/2015; 04222015@79, 7/21/2015; 05042015@49, 8/2/2015; 04222015@57, 7/21/2015; 04272015@19, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml + Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@48, 7/5/2015; 03232015@78, 5/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml + Methylcobalamin 0.05 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04152015@15, 6/14/2015; 03232015@64, 5/22/2015; 04222015@68, 6/21/2015; 04272015@86, 6/26/2015; 04292015@62, 6/28/2015; 05062015@5, 7/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml + Methylcobalamin 1 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03312015@25, 5/30/2015; 03312015@45, 5/30/2015; 03312015@50, 5/30/2015; 04292015@58, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml + MIC B-12 Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@55, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,100 IU/ml + Methylcobalamin 0.5 mg/ml Injection, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@21, 5/23/2015; 04132015@32, 6/12/2015; 04172015@45, 6/16/2015; 05052015@40, 7/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 15 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04152015@18, 6/14/2015; 04222015@25, 6/21/2015; 04292015@75, 6/28/2015; 05012015@41, 6/30/2015; 05042015@71, 7/3/2015; 05082015@61, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 2,500 IU/ml + Methylcobalamin 500 mcg/ml, Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@5, 5/23/2015; 05042015@78, 7/3/2015; 03262015@2, 5/25/2015; 04062015@52, 6/5/2015; 04242015@58, 6/23/2015; 05072015@17, 7/6/2015; 05082015@19, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04232015@36, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 23 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03272015@34, 5/26/2015; 05042015@32, 7/3/2015; 04102015@59, 6/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 40 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@19, 6/19/2015; 03272015@35, 5/26/2015; 05042015@59, 7/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 42 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05082015@49, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 5,000 IU/ml + Methylcobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@47, 5/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 5,000 IU/ml + Methylcobalamin 500 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04032015@53, 6/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@6,6/8/2015; 04202015@38, 6/19/2015; 04202015@8, 6/19/2015; 03202015@99, 5/22/2015; 03302015@54, 5/29/2015; 03312015@56, 5/30/2015; 04072015@7, 6/6/2015; 04062015@56, 6/5/2015; 04142015@86, 6/13/2015; 05052015@49, 7/4/2015; 05062015@30, 7/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 10,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03252015@5; 5/24/2015; 03232015@34, 5/22/2015; 04152015@40, 6/14/2015; 04072015@46, 6/6/2015; 04222015@16, 6/21/2015; 04302015@46, 6/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 2,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04292015@41, 6/28/2015; 05052015@80, 7/4/2015; 05062015@51, 7/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 625 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05072015@2, 7/6/2015; 04082015@25, 6/7/2015; 03042015@54, 6/2/2015; 04142015@16, 6/13/2015; 03312015@37, 5/30/2015; 04062015@75, 6/5/2015; 05112015@15, 7/10/2015; 04272015@21, 6/26/2015; 04272015@62, 6/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,250 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04162015@25, 6/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 11,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@59, 6/16/2015; 04302015@57, 6/29/2015; 03262015@39, 5/25/2015; 04012015@42, 5/31/2015; 04022015@18, 6/1/2015; 04302015@4, 6/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03302015@35, 5/29/2015; 04172015@15, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@78, 5/31/2015; 04222015@61, 6/21/2015; 04302015@55, 6/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 30 DAY KIT, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04132015@52, 6/12/2015; 04232015@26, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 2,500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03312015@18, 5/30/2015; 03252015@49, 5/24/2015; 04012015@60 5/31/2015; 05112015@59, 7/10/2015; 04062015@39, 6/5/2015; 04072015@25, 6/6/2015; 04072015@74, 6/6/2015; 04142015@44, 6/13/2015; 04172015@72, 6/16/2015; 04172015@77, 6/16/2015; 04232015@8, 6/22/2015; 04222015@60, 6/21/2015; 04242015@11, 6/23/2015; 04292015@33, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 3,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04062015@2, 6/5/2015; 04212015@76, 6/20/2015; 04272015@33, 6/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 4,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03262015@37, 5/25/2015; 04032015@4, 6/2/2015; 4292015@56, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 5,000 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03272015@23, 5/26/2015; 03312015@20, 5/30/2015; 04062015@4, 6/5/2015; 05112015@23, 7/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 1,200 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03272015@22, 5/26/2015; 04062015@19, 6/5/2015; 04212015@39, 6/20/2015; 04222015@62, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs HCG 500 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@59, 6/8/2015; 04162015@28, 6/15/2015; 03272015@2, 5/26/2015; 03302015@34, 5/29/2015; 04062015@71, 6/5/2015; 04162015@54, 6/15/2015; 05012015@36, 6/30/2015; 05112015@5, 7/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronic Acid Sodium 28 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03042015@6, 6/2/2015; 03122015@80, 6/10/2015; 03262015@43, 6/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronic Acid Sodium 32 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@42, 6/21/2015; 03252015@25, 6/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronic Acid Sodium 35 mg/ml + Lidocaine HCl 3 mg/ml Injection, ml Syringe, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04062015@66, 7/5/2015; 04072015@57, 7/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02202015@6, 5/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04132015@19, 7/12/2015; 02202015@12, 5/21/2015; 05112015@17, 8/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hyaluronidase 175 units/ml Injection, ml, Sterile, Preserved, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03112015@15, 6/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@64, 7/8/2015; 04032015@28, 7/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04272015@22, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@19, 7/20/2015; 02232015@28, 5/24/2015; 02252015@18, 5/26/2015; 03022015@12, 5/31/2015; 03302015@61, 6/28/2015; 04222015@11, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@74, 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 10 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02202015@5, 5/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@50, 6/14/2015; 04142015@81, 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@67, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@26, 6/7/2015; 03122015@95, 6/10/2015; 04132015@5, 6/12/2015; 04292015@8, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 20 mg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@86, 6/14/2015; 04142015@57, 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@93, 6/10/2015; 04242015@46, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@64, 6/14/2015; 04162015@53, 7/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@79, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@10, 5/31/2015; 04132015@4, 6/12/2015; 04222015@1, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 60 mg/ml + Bupivacaine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@59, 5/26/2015; 03202015@55, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 65 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@5, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@85, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydroxocobalamin 1,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@27, 6/18/2015; 04152015@1, 7/14/2015; 04222015@66, 7/21/2015; 05052015@5, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydroxocobalamin 10,000 mcg/ml Injection, Multi-Dose Vial, sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@52, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydroxocobalamin 5,000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03032015@4, 6/1/2015; 03312015@71, 6/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@28, 6/18/2015; 05042015@42, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04162015@27, 10/13/2015; 04032015@20, 9/30/2015; 04202015@47, 10/17/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs L-Arginine 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@50, 6/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lidocaine 1% Injection, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04062015@78, 7/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lidocaine 2% with Epinephrine 1:100,000 (Buffered) Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05122015@20, 5/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Magnesium Chloride 200 mg/ml (20%) Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@79, 7/19/2015; 04072015@24, 7/6/2015; 04222015@10, 7/21/2015; 05052015@4, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Magnesium Sulfate 500 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@31, 6/10/2015; 03202015@23, 6/18/2015; 05042015@79, 8/2/2015, 04272015@75, 7/26/2015; 04292015@61, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Mannitol 5% Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04072015@30, 7/6/2015; 05042015@23, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 25 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04222015@75, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@8, 7/20/2015; 03032015@11, 6/1/2015; 03102015@49, 6/8/2015; 03192015@9, 6/17/2015; 05042015@14, 8/2/2015; 04072015@20, 7/6/2015; 05042015@51, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 1,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@86, 5/31/2015; 04012015@71, 6/30/2015; 02202015@43, 5/21/2015,; 2232015@74, 5/24/2015; 02272015@70, 5/28/2015; 03052015@8, 6/3/2015; 03102015@61, 6/8/2015; 03092015@97, 6/7/2015; 03202015@98, 6/18/2015; 03232015@62, 6/21/2015; 03272015@50, 6/25/2015; 03312015@47, 6/29/2015; 04022015@20, 7/1/2015; 04062015@1, 7/5/2015; 04062015@61, 7/5/2015; 04132015@49, 7/12/2015; 04132015@53, 7/12/2015; 04152015@26, 7/14/2015; 04162015@20, 7/15/2015; 04222015@41, 7/21/2015; 04162015@50, 7/15/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 10,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03052015@5, 6/3/2015; 03162015@63, 6/14/2015; 04222015@70, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 4,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03062015@27, 6/4/2015; 03182015@45, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 5,000 mcg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03042015@15, 6/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 25,000 mcg/ml Intramuscular, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02192015@39, 5/20/2015; 03172015@46, 6/15/2015; 04162015@43, 7/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@36, 7/20/2015; 03202015@56, 6/18/2015; 03182015@10, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 1,000 mcg/ml + Hydroxocobalamin 1,000 mcg/ml Injectable, Preservative Free, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@81, 7/19/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02272015@17, 5/28/2015; 04082015@47, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MIC+Methylcobalamin 4000 mcg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03172015@50, 6/15/2015; 04142015@11, 7/13/2015; 03232015@32, 6/21/2015; 03232015@37, 6/21/2015; 03302015@53, 6/28/2015; 04142015@10, 7/13/2015; 04302015@47, 7/29/2015; 04292015@84, 7/28/2015; 05042015@55, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MIC-B COMPLEX Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02242015@38, 5/25/2015; 05082015@25, 8/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MIC-B12+B6 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@93, 5/24/2015; 03132015@21, 6/11/2015, 04062015@38, 7/5/2015; 04082015@17, 7/7/2015; 04272015@83, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MIC-PLUS Carnitine Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@29, 5/26/2015; 03112015@36, 6/9/2015; 03192015@18, 6/17/2015; 04162015@40, 7/15/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Mitomycin 0.03% Ophthalmic Solution, ml single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05112015@22, 5/10/2016; 10202014@63, 10/20/2015; 10272014@17, 10/27/2015; 11102014@20, 11/10/2015; 12302014@8, 12/30/2015; 08252014@26, 8/25/2015; 08262014@20, 8/26/2015; 09052014@13, 9/5/2015; 01262015@15, 1/26/2016; 01022015@22, 1/2/2016; 02232015@50, 2/23/2016; 04132015@59, 4/12/2016; 04222015@40, 4/21/2016; 05062015@21, 5/5/2016; 06042014@17, 6/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 10222014@55, 10/22/2015; 10032014@43, 10/3/2015; 12012014@42, 12/1/2015; 01092015@35, 1/9/2016; 02022015@52, 2/2/2016; 02232015@78, 2/23/2016; 03122015@81, 3/11/2016; 03312015@38, 3/30/2016 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03102015@55, 3/9/2016; 03172015@62, 3/16/2016; 04102015@7, 4/9/2016 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@1, 5/26/2015; 03062015@38, 6/4/2015; 03162015@77, 6/14/2015; 03242015@44, 6/22/2015; 03242015@51, 6/22/2015; 04072015@58, 7/6/2015; 04132015@6, 6/12/2015; 04142015@60, 6/13/2015; 04222015@12, 6/21/2015; 05122015@16, 7/11/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 12.5 mg/ml Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@13, 5/31/2015; 03162015@51, 6/14/2015; 04072015@59, 7/6/2015; 04272015@26, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 15 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@54, 6/14/2015; 04222015@14, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 20 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@98, 6/10/2015; 03162015@57, 6/14/2015; 03162015@79, 6/14/2015; 04062015@42, 7/5/2015; 05042015@4, 7/2/2015; 05042015@69, 7/3/2015; 05122015@17, 7/11/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 20 mg/ml + Clonidine 400 mcg/ml Solution Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@81, 5/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 20 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@11, 6/7/2015; 03302015@7, 6/28/2015; 4242015@50, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 25 mg/ml + Baclofen 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@22, 5/31/2015; 04072015@66, 7/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@2, 5/26/2015; 03022015@14, 5/31/2015; 03242015@63, 6/22/2015; 04072015@62, 7/6/2015; 04222015@15, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 30 mg/ml + Baclofen 10 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@74, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 30 mg/ml + Bupivacaine 5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@10, 5/26/2015; 03242015@75, 6/22/2015; 04222015@20, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 30 mg/ml + Clonidine 250 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@20, 6/7/2015; 03202015@72, 6/18/2015; 04132015@9, 6/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 33 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@68, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 35 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@64, 7/13/2015; 02252015@4, 5/26/2015; 03162015@59, 6/14/2015; 03242015@71, 6/22/2015; 04222015@17, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 36 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile- Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@83, 5/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@5, 5/26/2015; 03022015@19, 5/31/2015; 04062015@48, 7/5/2015; 04212015@23, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@7, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@3, 8/2/2015; 03122015@101, 5/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Fentanyl 2,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@73, 7/13/2015; 03162015@65, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@4, 6/10/2015; 05012015@22, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 45 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 45 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@80; 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Bupivacaine 2.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@77, 6/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02272015@33, 5/28/2015; 04012015@3, 6/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03222015@23, 5/31/2015; 04072015@68, 7/6/2015; 04142015@76, 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml +Fentanyl 1,000 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@4, 5/31/2015; 03092015@12, 6/7/2015; 03302015@5, 6/28/2015; 04172015@44, 6/16/2015; 04032015@29, 7/202015; 04242015@57, 6/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 60 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@19, 5/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@4, 6/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03222015@80, 5/31/2015; 03202015@77, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@22, 5/24/2015; 03202015@81, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Nandrolone Decanoate 200 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015: 02272015@1, 8/26/2015; 12182015@67, 6/16/2015; 02062015@141, 8/5/2015; 04222015@13, 9/29/2015; 04072015@33, 10/4/2015; 04212015@13, 10/18/2015; 04082015@7, 10/5/2015 ; 04142015@24, 10/11/2015; 04272015@84, 10/24/2015; and 05082015@7, 11/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Nandrolone Decanoate 250 mg/ml Injection, ml Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@49, 9/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 01282015@15 and 03182015@54 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03102015@4 6/8/2015 03052015@29 6/3/2015 04272015@37 7/26/2015 05042015@17 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@33, 04272015@36 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs PGE 40 (Alprostadil) 40 mcg/ml Injection, ml, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@31, 8/10/2015; 03132015@28, 9/9/2015; 03272015@5, 9/23/2015; 03262015@17, 9/22/2015; 03272015@17, 9/23/2015; 04012015@28, 9/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@32, 8/10/2015; 04012015@30, 9/28/2015; 04272015@38, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05112015@18, 8/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Polidocanol 1% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04102015@36, 7/9/2015; 03252015@36, 6/23/2015; 04012015@77, 6/30/2015; 04162015@49, 7/15/2015; 04292015@83; 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Polidocanol 5% Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@45, 8/4/2015, 02272015@13, 5/28/2015, 03102015@46, 6/8/2015, 04172015@17, 7/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Progesterone 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04292015@66, 10/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Pyridoxine Hydrochloride 100 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, Protect from Light, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03122015@6/102015; 03202015@29, 6/18/2015, 03232015@3, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Selenium 200 mcg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04162015@17, 7/15/2015; 03202015@25, 6/18/2015; 03272015@36, 6/25/2015; 04292015@89, 7/28/2015, and 05042015@52, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@84, 6/8/2015; 04062015@55, 6/5/2015; 04222015@104, 6/21/2015; 04292015@47, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@9, 6/8/2015; 04152015@59, 6/14/2015; 04042015@26, 6/6/2015; 04132015@36, 6/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05072015@31, 7/6/2015; 03232015@11, 5/22/2015; 03302015@44, 5/29/2015; 03272015@16, 5/26/2015; 04222015@81, 6/1/2015; 04032015@15, 6/2/2015; 04142015@9, 6/13/2015; 04232015@11, 6/22/2015; 04272015@42, 6/26/2015; 04292015@86, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@91, 5/23/2015; 04012015@50, 5/31/2015; 04242015, 6/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@76, 5/31/2015, 04062015@11, 6/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sodium Ascorbate 500 mg/ml Injection, Preservative Free Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@78, 7/19/2015; 02242015@9, 5/25/2015; 03162015@75, 6/14/2015; 03312015@70, 6/29/2015; 04292015@87, 7/28/2015; 05042015@41, 8/2/2015; 04212015@16, 7/20/2015; 02242015@54, 5/25/2015; and 04222015@65, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sodium Tetradecyl Sulfate 5% Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03312015@58, 6/29/2015; and 04012015@68, 6/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sufentanil 45 mcg/ml + Bupivacaine 5 mg/ml Solution, Sterile=Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 04142015@70, 7/13/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sufentanil 50 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03112015@2, 6/9/2015; 03162015@6/14/2015; 03242015@2, 6/22/2015, 03302015@62, 6/28/2015, 0406201@43, 7/5/2015; 04142015@62, 7/13/2015, 04122015@6/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Sufentanil 50 mcg/ml + Bupivacaine 0.25 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@27, 6/2062015; 02272015@42, 5/28/2015; 03112015@3, 6/9/2015; 03162015@85, 6/14/2015; 03242015@3, 6/22/2015; 03302015@63, 6/28/2015, 04062015@44, 7/5/2015; 04142015@63, 7/13/2015; 04212015@28, 6/20/2015; and 05072015@8, 7/6/2015, Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs SUPER LIPO Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03312015@51, 6/11/2015; 04142015@18, 7/13/2015; 03302015, 6/28/2015; 04302015@48, 7/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@65, 10/6/2015; 04162015@52, 10/13/2015; 03132015@16, 9/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 150 mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03202015@1, 9/16/2015, 01192015@54, 7/18/2015; 04082015@4, 10/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 200mg/ml Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01142015@3, 7/13/2015; 01142015@13, 7/13/2015; 03032015@47, 8/30/2015; 05042015@33, 10/31/2015; 11242014@30, 5/23/2015; 11242014@34, 5/23/2015; 12182014@79, 6/16/2015; 12232014@4, 6/21/2015; 01232015@28, 7/22/2015; 01142015@17, 7/13/2015; 01302015@6, 7/29/2015; 02022015@5, 8/1/2015; 04092015@10, 10/6/2015; 02162015@4, 8/15/2015; 02192015@19, 8/18/2015; 03032015@48, 8/30/2015; 03202015@100, 9/16/2015; 03202015@11, 9/16/2015; 04132015@18, 10/10/2015; 04202015@14, 10/17/2015; 03302015@12, 9/26/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@10/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 200 mg/ml Anastrazole 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@56, 10/14/2015; 04202015@32, 10/17/2015; 049057, 10/21/2015; 05052015@69 11/1/2015; 05082015@43, 11/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 200 mg/ml Anastrazole 2 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 200 mg/ml Anastrazole 0.25 mg/ml Cholecalciferol 50,000 U/ml, Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04202015@66, 10/17/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12022014@35, 5/31/2015; 01122015@40, 7/11/2015; 12312014@28, 6/29/2015; 03022015@71, 8/29/2015; 03122015@1, 9/8/2015; 04222015@2, 10/19/2015; 04282015@48, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone USP Aqueous 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015@27, 9/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Propionate 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04302015@39, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone USP (10 AQUEOUS) 100 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01122015@25, 7/11/2015; 02232015@48, 8/22/2015; 03242015, 9/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN All lots distributed between November 2014 and May 2015; 12032014@47, 6/1/2015; 12052014@36, 6/3/2015; 12192014@33, 6/17/2015; 01202015@53, 7/19/2015; 01062015@58, 7/5/2015; 02122015@40, 8/11/2015; 03022015@15, 8/29/2015; 03252015@22, 9/21/2015; 05082015@6, 11/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 62.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 05062015@31, 11/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 70 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 72.5 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01122015@63, 7/11/2015; 03162015@9, 9/12/2015; 03232015@13, 9/19/2015; 05012015@23, 10/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 75 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05072015@42, 11/3/2015; 12292014@9, 6/27/2015; 12032014@12, 6/1/2015; 12042014@73, 6/2/2015; 02272015@63, 8/26/2015; 05042015@44, 10/31/2015; 03302015@9, 9/26/2015; 04092015@46, 10/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 80 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 11212014@51, 5/20/2015; 02232015@24, 8/22/2015; 05062015@27, 11/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 60 mg Anastrazole 4 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12032014@36, 6/1/2015; 12082014@22, 6/6/2015; 01202015@19, 7/19/2015; 05042015@81, 10/31/2015; 05112015@19, 11/7/2015; 04282015@44, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 200 mg Anastrazole 1 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@38, 9/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01292015@32, 7/28/2015; 02232015@18, 5/20/2015; 02272015@31, 8/26/2015; 03092015@23, 9/5/2015; 03272015@32, 9/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 75 mg and B12 6 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02242015@49, 8/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Vancomycin 25 mg/ml Ophthalmic Solution, Single Dose, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03102015@34 6/8/2015; 03042015@43, 6/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Zinc 5 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04292015@91, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Zinc Chloride 25mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05042015@54, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Bi-Mix #1 (17.365 mg/0.59 mg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@40, 8/10/2015; 03132015@26, 7/20/2015; 04012015@11, 9/28/2015; 04272015@51, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Bi-Mix (20/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@34, 9/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Bi-Mix Medium (30/1) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12022014@48, 5/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Buckshot Injectable, Multi-Dose, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@2, 6/21/2015; 05052015@8, 8/3/2015; 04222015@7, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Calmme Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@1, 6/21/2015; 04222015@8, 7/21/2015; 05052015@7, 8/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 04142015@68, 7/13/2015; 03162015@67, 5/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 20 mg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@8, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 3 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@5, 5/31/2015; 03202015@53, 6/18/2015; 04172015@37, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03242015@81, 6/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 35 mg/ml + Bupivacaine 4 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03232015@18, 6/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@8, 5/31/2015, 03202015@60, 6/18/2015; 04172015@29, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04072015@70, 7/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@21, 6/10/2015; 04092015@71, 6/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@61, 6/18/2015; 04172015@38, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@17, 6/7/2015, 04032015@26, 7/2/2015; 5012015@15, 7/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 70 mg/ml + Bupivacaine 20 mg/ml + Clonidine 125 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@19, 6/10/2015; 04242015@48, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@24, 6/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 80 mg/ml + Bupivacaine 10 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@58, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipo-B MMC I (SULFUR FREE) Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04222015@13, 7/21/2015; 05112015@74, 8/9/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipo-DEN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@26, 5/31/2015; 02272015@22, 5/28/2015; 03092015@75, 6/7/2015; 04092015@97, 7/8/2015; 04092015@37, 7/8/2015; 03022015@78, 5/31/2015; 04102015@6, 7/9/2015; 04242015@31, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPO-DEN MODIFIED Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@68, 5/31/2015; 04102015@4, 7/9/2015; 04242015@23, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPO-EXTREME Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@79, 6/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02262015@3, 5/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPO-VITE Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@27, 5/31/2015; 02242015@4, 5/25/2015; 02272015@4, 5/28/2015; 03052015@1, 6/3/2015; 03132015@49, 6/11/2015; 03162015@29, 6/14/2015; 03182015@1, 6/16/2015; 03172015@13, 6/15/2015; 03172015@17, 6/15/2015; 03172015@20, 6/15/2015; 03182015@18, 6/16/2015; 03232015@14, 6/21/2015; 04272015@57, 7/26/2015; 03302015@31, 6/28/2015; 04092015@24, 7/8/2015; 03312015@46, 6/29/2015; 03312015@55, 6/29/2015; 04022015@61, 7/1/2015; 04032015@17, 7/2/2015; 04072015@11, 7/6/2015; 04072015@11, 7/6/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPO-VITE III, Injection Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02232015@72, 5/24/2015; 02252015@60, 5/26/2015; 03112015@55, 6/9/2015; 03122015@99, 6/10/2015; 03172015@67, 6/15/2015; 03312015@74, 6/29/2015; 05052015@34, 8/3/2015; 04292015@21, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipotropic (w/Cyanocobalamin 4000 mcg/ml) Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@1, 7/31/2015; 04152015@62, 7/14/2015; 03232015@53, 6/21/2015; 03232015@75, 6/21/2015; 04152015@11, 7/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipotropic B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03042015@17, 6/2/2015; 04142015@20, 7/13/2015; 03192015@51, 6/17/2015; 04142015@89, 7/13/2015; 04232015@3, 7/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipotropic B-12 II* + Lidocaine Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04132015@63, 7/12/2015; 03182015@34, 6/16/2015; 05082015@26, 8/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipotropic Methyl B-12 Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03102015@62, 6/8/2015; 03172015@52, 6/15/2015; 03272015@8, 6/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipovicine Modified II Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04152015@29; 7/14/2015; 04212015@31, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Lipovicine-Choline 100 mg/ml-Acorbic Acid 45 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03182015@17, 6/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04212015@10, 7/20/2015; 02232015@86, 5/24/2015; 02252015@79, 5/26/2015; 03112015@21, 6/9/2015; 03232015@40, 6/21/2015; 03242015@76, 6/22/2015; 03312015@60, 6/29/2015; 03272015@27, 6/25/2015; 04022015@62, 7/1/2015; 04072015@55, 7/6/2015; 04142015@59, 7/13/2015; 04212015@30, 7/20/2015; 04212015@54, 7/20/2015; 04222015@31, 7/21/2015; 05042015@64, 8/2/2015; 05052015@60, 8/3/2015; 04272015@77, 7/26/2015; 04292015@14, 7/28/2015; 04292015@23, 7/28/2015; 05052015@92, 8/3/2015; 05082015@23, 8/6/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN Injectable ROCK CREEK, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02272015@77, 5/28/2015; 03122015@85, 6/10/2015; 03252015@29, 6/23/2015; 04072015@54, 7/6/2015; 04172015@69, 7/16/2015; 04272015@45, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN IV Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@6, 7/13/2015; 03132015@9, 6/11/2015; 03122015@100, 6/10/2015; 04142015@15, 7/13/2015; 03302015@46, 6/28/2015; 04302015@49, 7/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN* Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@61, 5/31/2015; 03052015@11, 6/3/2015; 04132015@21, 7/12/2015; 03242015@7, 6/22/2015; 04292015@11, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@14, 6/7/2015; 04242015@54, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 25 mg/ml + Bupivacaine 30 mg/ml + Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@84, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02272015@35, 5/28/2015; 04222015@23, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Clonidine 500 mcg/ml +Bupivacaine 2.5 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@6, 6/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@25, 6/7/2015; 04242015@44, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 1,500 mcg/ml + Baclofen 800 mcg/ml +Clonidine 200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@12, 5/20/2015; 03242015@80, 6/22/2015; 04222015@24, 7/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03092015@15, 6/7/2015; 04092015@69, 6/8/2015; 05012015@12, 6/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@70, 6/14/2015; 04142015@72, 5/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03202015@57, 6/18/2015; 04242015@53, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 3,000 mcg/ml + Bupivacaine 15 mg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05082015@38, 7/7/2015; 03122015@15, 6/10/2015; 04092015@72, 6/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Ropivacaine 5 mg/ml +Baclofen 20 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04072015@69, 7/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 50 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@23, 6/10/2015; 04092015@73, 6/8/2015; 05082015@39, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 60 mg/ml + Fentanyl 12,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,400 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@69, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Myers Cocktail Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05072015@9, 6/11/2015; 05062015@39, 6/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MYO-DEN Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03062015@29, 6/4/2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Quad-Mix 1 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@26, 8/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Quad-Mix 2 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@16, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Quad-Mix 4 Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@27, 8/10/2015; 02032015@93, 8/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs TRI-MIX (1/1/40) (MFG) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03042015@7, 8/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix Super Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (15 mg/0.5 mg/20 mcg) Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Vitatrim Injection, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04102015@70, 7/9/2015; 04212015@9, 7/20/2015; 04092015@75, 7/8/2015; 03022015@1, 5/31/2015; 04202015@12, 7/19/2015; 03112015@19, 6/9/2015; 03032015@36, 6/1/2015; 03032015@40, 6/1/2015; 03062015@28, 6/4/2015; 03192015@5, 6/17/2015; 03202015@15, 6/18/2015; 03172015@18, 6/15/2015; 03172015@27, 7/13/2015; 03202015@87, 6/18/2015; 03242015@35, 6/22/2015; 05042015@76, 8/2/2015; 03272015@9, 6/25/2015; 03312015@14, 6/29/2015; 03272015@33, 6/25/2015; 03272015@43, 6/25/2015; 04012015@37, 6/30/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Vitatrim Active Injectable, Multi-Dose Vial, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04152015@28, 7/14/2015; 04212015@29, 7/20/2015; 04212015@37, 7/20/2015; 04172015@10, 7/16/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04022015@36, 7/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs B-Complex 100 mg/ml Injection, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02202015@47 5/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Betamethasone Sodium Phosphate (10 ml) 30 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12122015@76, 6/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Fentanyl 5,000 mcg/ml + Bupivacaine 40 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@82, 5/31/2015; 03202015@69, 6/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@82, 6/8/2015; 05082015@37, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 80 mg/ml + Clonidine 1,800 mcg/ml + Baclofen 730 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04242015@52, 7/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@6, 5/31/2015; 04172015@25, 6/16/2015; 05082015@35, 7/7/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml + Baclofen 750 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04272015@27, 6/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPOLEAN Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05082015@29, 8/6/2015; 04022015@43, 7/1/2015; 04242015@32, 7/23/2015; 04282015@37, 7/27/2015; 04292015@97, 7/28/2015; 04302015@61, 7/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs LIPOLEAN + Ascorbic Acid 50 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04132015@56, 7/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MEGA-BURN, Winning at Weight Loss Formula Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04292015@11, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 30 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02252015@3, 5/26/2015; 03022015@17, 5/31/2015; 03162015@60, 6/14/2015; 04012015@1, 6/30/2015; 04142015@66, 7/13/2015; 04272015@28, 6/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03162015@6, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Morphine 40 mg/ml + Bupivacaine 16 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03162015@7, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02192015@44, 5/20/2015; 03162015@87, 6/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs PGE 2 (Alprostadil) 100 mcg/ml, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04282015@46, 10/25/2015; 04302015@31, 10/27/2015; 05072015@36, 11/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02092015@20, 8/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01082015@1, 7/7/2015; 11212014@6, 5/20/2015; 11212014@8, 5/20/2015; 1242014@51, 5/23/2015, 11262014@72, 5/25/2015, 01152015@29, 7/14/2015; 02112015@12, 8/10/2015; 12192014@6, 6/17/2015; 12012014@57, 5/30/2015; 12022014@33; 5/31/2015; 12042014@50, 6/2/2015; 12152014@10, 6/13/2015; 12082014@38; 6/6/2015; 12182014@18, 6/16/2015; 12092014@62, 6/7/2015; 12292014@37, 6/27/2015; 12292014@72, 6/29/2015; 01222015@44, 7/21/2015; 01052015@3, 7/4/2015; 01092015@9, 7/8/2015; 01202015@42; 7/19/2015;  ...
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Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; 04302015@53, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03032015@43, 8/30/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12102014@3, 6/8/2015; 12042014@62, 6/2/2015; 01192015@15, 7/18/2015; 01062015@12, 7/5/2015; 02202015@23, 8/19/2015; 02242015@35, 8/23/2015; 03032015@17, 8/30/2015; 03252015@9, 9/21/2015; 04292015@19, 10/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 30 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02192015@41, 8/18/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 37.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@79, 8/29/2015; 12092014@5, 6/7/2015; 12042014@28, 6/2/2015; 01152015@30, 7/14/2015; 04152015@24, 10/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 60 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04282015@24, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 70 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12182014@19, 6/16/2015; 03192015@38, 9/15/2015; 04072015@9, 10/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone 87.5 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@60, 8/29/2015; 12042014@65, 6/2/2015; 12182014@39, 6/16/2015; 01152015@37, 7/14/2015; 01052015@1, 7/4/2015; 02052015@50, 8/4/2015; 02132015@14, 8/12/2015; 03162015@14, 9/12/2015; 03252015@14, 9/21/2015; 04222015@44, 10/19/2015, 05042015@28, 10/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03252015@48, 9/21/15 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03252015@48, 9/21/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 50 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02022015@1, 8/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01222015@34, 7/21/2015; 03172015@80, 9/13/2015; 04092015@65, 10/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 220 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 11242014@36, 5/23/2015; 12042014@53, 6/2/2015; 12222014@67, 6/20/2015; 02192015@5, 8/18/2015, 05042015@77, 10/31/2015; 05052015@54, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 40 mg/ml (10 ml Sesame Oil), Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04092015@12, 10/6/2015; 03122015@13, 9/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 250 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01292015@59, 7/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04152015@56, 10/12/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Testosterone Tri-Blend 200 mg/ml (10 ml Sesame Oil) Injection, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01122015@49, 7/11/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (10/0.174/16) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04142015@61, 10/11/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (15 mg/0.5 mg/5 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01212015@40, 7/20/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (17 mg/0.5 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05072015@6, 11/3/2015, 05052015@77, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (17.7 mg/1 mg/10 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 05012015@2, 10/28/2015; 02232015@9, 8/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (17.7/0.59/6) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12192014@10, 6/17/2015; 12022014@4, 5/31/2015; 12302014@56, 6/28/2015; 01262015@84, 7/25/2015, 03302015@51, 9/26/2015; 05052015@83, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (18 mg/0.6 mg/5.88 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01262015@6, 7/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (18/0.6/5.88) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01232015@45, 7/22/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (20/1/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04292015@78, 10/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (20/2.5/20) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03102015@57 9/6/2015 03092015@71 9/5/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (22.5/0.83/8.3) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01272015@51, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (25/2.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01202015@49, 7/19/2015; 04082015@12, 10/5/2015; 04282015@6, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (25/2.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01202015@32, 7/19/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/0.5/10) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01262015@50, 7/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/0.5/10) (MFG) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12302014@48, 6/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/10) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12022014@50, 5/31/2015; 01092015@31, 7/8/2015; 02102015@43, 8/9/2015; 03272015@42, 9/23/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05082015@94, 11/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05082015@31, 11/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/22) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03112015@1, 9/7/2015; 01272015@24, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/1/22) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01272015@21, 7/26/2015; 03102015@52, 9/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03042015@5, 8/31/2015; 03122015@51, 9/8/2015; 04072015@27, 10/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (30/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03122015@17, 9/8/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (37.5 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 03042015@18, 8/31/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (37.5/2/20) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01162015@4, 7/15/2015; 02272015@47, 8/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (37.5/2/20) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01152015@60, 7/14/2015; 02272015@34, 8/26/2015; 04012015@27, 9/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix (6.9/0.575/39.375) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04132015@17, 10/10/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix AT-1 (8 mg/2 mg/0.2 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@57, 9/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix AT-6 (60 mg/4 mg/0.3 mg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@39, 8/10/2015; 02032015@99, 8/2/2015; 04012015@25, 9/28/2015; 04272015@55, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix MEDIUM (15 mg/0.5 mg/5 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 12182014@66, 6/16/2015; 01052015@51, 7/4/2015; 01192015@33, 7/18/2015; 02192015@9, 8/18/2015; 05042015@38, 10/31/2015; 04012015@63, 9/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix MEDIUM (15/0.5/5) (MFG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01052015@48, 7/4/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST1 (30 mg/1.5 mg/50 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@15, 8/10/2015 04012015@18 9/28/2015 04272015@52 10/24/2015 05052015@14 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST2 (30 mg/3 mg/100 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04302015@29, 10/27/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST2/LIDO2/PGE2 0.2/0.1/0.04, Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 04292015@57, 10/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST3/PGE 2/LIDO 2 0.06/0.2/0.02 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 03022015@76, 8/29/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST4 (3 mg/1.5 mg/300 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01272015@29, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST4/PGE 2/LIDO 2 0.1/0.05/0.05 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01272015@28, 7/26/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST9A (30 MG/2 MG/80 MCG) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST9A (30 mg/2 mg/80 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@19, 8/10/2015; 02032015@77, 8/2/2015; 04012015@19, 9/28/2015; 04272015@54, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST9C (30 mg/2 mg/120 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@22, 8/10/2015; 02032015@87, 8/2/2015; 05062015@3, 11/2/2015; 04272015@53, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix ST9E (60 mg/4 mg/150 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@24, 8/10/2015; 02032015@101, 8/2/2015, 04012015@21, 9/28/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix SUPER (28 mg/0.9 mg/37 mcg) Injectable, Sterile Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01202015@30, 7/19/2015; 01262015@22, 7/25/2015; 02092015@14, 7/1/2015; 02192015@12, 8/18/2015; 03202015@86, 9/16/2015; 03232015@25, 9/19/2015; 04282015@14, 10/25/2015; 04282015@18, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-101 (17.65 mg/0.59 mg/5.9 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02112015@9, 8/10/2015; 02032015@25, 8/2/2015; 04012015@14, 9/28/2015; 05052015@10, 11/1/2015; 04272015@43, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-102 (17.65 mg/0.59 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@20, 11/3/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05062015@38, 11/2/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-105 (30 mg/1 mg/10 mcg) Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 05052015@11, 11/1/2015; 02112015@11, 8/10/2015; 02032015@28, 8/2/2015; 04012015@16, 9/26/2015; 04272015@47, 10/24/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-106 (30 mg/1 mg/25 mcg) Injectable,The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 02032015@57, 8/2/2015; 02112015@14, 8/10/2015; 04012015@17, 9/28/2015; 04272015@49, 10/24/2015; 05052015@12, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-106/PGE 2 0.1/0.14 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04172015@7, 10/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04012015@23, 9/28/2015; 04272015@41, 10/24/2015; 05052015@9, 11/1/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 001072015@39, 7/6/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 01152015@46, 7/14/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Drugs Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable, The Compounding Pharmacy of America, Knoxville, TN All lots distributed between November 2014 and May 2015; 04282015@33, 10/25/2015 Class II Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility The Compounding Pharmacy of America
Devices Radiation Therapy Treatment Planning System software RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. software build numbers are 4.7.0.15 or 4.7.1.10 Class II An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images RAYSEARCH LABORATORIES AB
Devices Sony LMD-1951MD Sony LMD1951MD/BS. The above are identical products. Sony LMD-1951MC (Foreign) Sony LMD-1951MD 3000038-3004884, 3100035-3100058, 3100065-3100145 Sony LMD-1951MC (Foreign) 5000001-5001925 5100001-5100157 Class II Sony Electronics Inc. is recalling LMD-1951MD 19 inch medical grade liquid crystal display (LCD) monitors with light-emitting diode (LED) backlight technology since the medical monitor has either not turned on or has lost image during clinical use. Sony Medical Systems
Devices This product is a medical endoscope for the duodenum and upper G.I. tract. ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681 Class II FujiFilm is initiating a voluntary field correction involving ED-530XT Operation Manual, ED-250XL5 and ED-250XT5 Operation Manual and ED-450XL5 and ED-450XT5 Operation Manual because FMSU-ESD has become aware of events in which the suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures. Fujifilm Medical Systems U.S.A., Inc.
Veterinary Dingo chip Twists "Chicken in the Middle" packed 6 per bag Net Wt. 3.9 oz. (UPC 615650300600) and 16 per bag Net Wt. 9.59 oz. (UPC 615650990429) for dogs. The responsible name on the label is United Pet Group, Inc. Cincinnati, OH. Product is made in China. 6-pack: Best by Date 5/16/2017 16-pack: Best by Date 12/27/2015 & 5/16/2017 Class III Product may be contaminated with Amantadine, an antiviral human drug not approved for use in animal food. United Pet Group Div Of Spectrum Brans Inc
Drugs IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Lot #: Kit: 071374; IC-Green: 041514, Exp 10/16 Class III Subpotent Drug: Low out-of-specification potency result of the drug product. Akorn, Inc.
Food KellBran" CANDIES, INC. creamy rich caramel popcorn Net Wt. 8 oz. (226.64 Grams) ALLERGY INFO: Manufactured in a facility that processes peanuts, nuts, soy and milk. UPC 0 96637 50153 9 kellbrancandies.com KellBran Candies, Inc. Akron, Ohio 44312 Best Used By: Class II The firm was notified by the Ohio Dept. of Agriculture of possible mislabeling with their Allergen declaration of undeclared milk. Kellbran Candies and Snacks Inc
Biologics Red Blood Cells Leukocytes Reduced W041115065175C Class III Blood product, collected from a donor who resided in an area considered endemic for malaria, was distributed. Blood Systems, Inc. dba United Blood Services Texas
Drugs Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540 Lot #: F0002, Exp 12/2016 Class III Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing. Novartis Pharmaceuticals Corp.
Food Valley View Orchard Pies, Raspberry Rhubarb Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Food Valley View Orchard Pies, Pecan Pie Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Food Valley View Orchard Pies, Apple Crisp Pie Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Food Valley View Orchard Pies, Blueberry Crisp Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Food Valley View Orchard Pies, Bumbleberry Pie Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Food Valley View Orchard Pies, Apple Crisp Tray Product delivered on or prior to July 23, 2015. Class II Undeclared soy lecithin. Valley View Orchard Pies Inc.
Devices Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited. GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall. Class II There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. Lumenis
Devices CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. 010713325 010713325 010713324 010713326 010713324 020713327 010713327 010713327 020713327 090713339 020713331 090713339 090713343 090713343 090713345 100713347 110713352 120713353 120713352 100713347 110713352 120713353 150713355 150713356 150713354 160713360 150713356 150713354 150713354 170713361 170713363 170713362 170713363 170713361 170713364 180713368 190713368 190713369 180713368 190713369 290713370 290713370 050813376 050813377 050813377 050813378 070813384 060813379 050813378 070813384  ...
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Class II Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use). Advanced Sterilization Products
Devices Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital. Part Number: 595000-001 Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 85979-013 85979 031479 4506 85979-022 85979 031479 4506 85977-033 85977 031333 4507  ...
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Class I SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function. SynCardia Systems Inc.
Devices NebuTech Nebulizer Model number: Series 8660, 8960, 8961, 8966, 8984 Product usage - The product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment. Lot numbers: 042015 through 070615A Model number: Series 8660, 8960, 8961, 8966, 8984 Class II Salter Labs is recalling NebuTech nebulizers (part numbers 8660-7, 8960-7, 8960TG-7, 8967-7, 8982-7, 8984-7) that the Inspiratory valve cap, part #600116 because the nebulizer reservoir tower may be loose and may detach before or during treatment. Salter Labs
Devices The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration. Product Code: Leica ASP200S/ASP300S with Serial Numbers: 5682; 5886; 5264; 5267; 5356; 5259; 5956; 5946; 5794; 5385; 5929; 5301; 5401; 5310; 5530; 5909; 5804; 5272; 5724; 5796; 5807; 5446; 5435; 5670; 5947; 5348; 5434; 5388; 5366; 6000; 6131; 5407; 6040; 5799; 5815; 5737; 5706; 5381; 5416; 5673; 5875; 5962; 6041; 6042; 5266; 5948; 5693; 6021; 5610; 5798;  ...
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Class III The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure. Leica Microsystems, Inc.
Biologics Red Blood Cells W286814034832 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. LifeSource
Biologics Cryoprecipitated AHF W286814034832 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. LifeSource
Biologics Blood and Blood Products for Reprocessing W286814034832 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. LifeSource
Devices CIVCO Shoulder Retractors, Reusable non-sterile hand grip, REF 302070, packaged 1 set per box, RX. For use in patient positioning. The grips are used for pulling down the shoulders during radiotherapy simulation and treatment sessions where opposed lateral fields are used in the neck area. Lot numbers M765570 and M784310. Class II The wrist straps used for positioning the patient are too long Med Tec Inc
Drugs Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05 Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016 Class II Defective Container: There were customer complaints of cracked and leaking glass vials. Hospira Inc.
Biologics Red Blood Cells Leukocytes Reduced W089215004427 Class II Blood product, for which the manufacturer's instructions for leukoreduction were not followed, was distributed. Sanford Medical Center (Blood Bank)
Food Kariba Farms Macadamia Meal, 1 pound bags; Packed by: Kariba Farms, Denville, NJ 07834 Product of USA. www.KaribaFarms.com 1.800.442.1969. Lot number 150030 Class I Product may be contaminated with Salmonella. Kariba Farms, Inc.
Devices Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle, PP plastic caps. Bulk: PE plastic cube containers, PP plastic caps. Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only. Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402 Class III Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. Pointe Scientific, Inc.
Devices Voyant Open Fusion Device Models: EB040 and EB040+ Product Usage: The Applied Voyant Open Fusion Device is designed for use with the Voyant Electrosurgical Generator. The device is an advanced bipolar instrument that uses RF energy, provided by the generator, to seal vessels up to and including 5mm (EB040+) or 7mm (EB040) in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The system delivers the energy required to fuse the tissue between the jaws of the device by monitoring voltage and current throughout the seal cycle. The device also features a useractuated blade for the transection of sealed tissue. Model Number: EB040 Lot Numbers: 1243964, 1243975, 1244125 Model Number: EB040+ Lot Numbers: 1245512, 1245513, 1246241, 1246508, 1247079, 1247566, 1248102, 1249264 Class II Potential to improperly characterize tissue within the jaws, which may result in nonoptimal power delivery. Applied Medical Resources Corp
Biologics Fresh Frozen Plasma W115115115410V Class III Blood product, labeled with an incorrect volume, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Devices Pressure Monitoring Kit The Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer is a sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. The disposable sterile cable interfaces exclusively with an Edwards cable that is specifically wired for the monitor being use. The TruWave disposable pressure transducer has a straight flow-through design across the pressure sensor, and is available with or without integral flush device. Model # Lot # Expiration Date PX2X3 59987950 3/12/2017 PX2X3 60008882 3/24/2017 PX2X3 60043561 5/1/2017 PX3X3272 59994227 3/8/2017 PX3X3272 60025936 4/15/2017 PX3X3AN 60030889 4/17/2017 PX3X3AN 60008883 3/26/2017 PXAK2066 60025499 2/27/2017 PXAVMP3 60036757 4/27/2017 PXMK1970 60001398 4/16/2017 PXMK2043 59994210 3/9/2017 PXMK2043 60001412 3/17/2017 PXMK2043 60020166 4/5/2017 PXMK2043 60030868 4/26/2017 PXMK2144 60019038 4/17/2017 PXMK2217 59994267 3/12/2017 PXMK2217 60030969 4/20/2017 PXMK2217 60020235 4/15/2017 PXVK0458 59983333 4/6/2017 PXVK1079 59994195 3/11/2017 PXVK1079 60020153 3/31/2017 PXVMP2X31 59998630 3/12/2017 PXVMP2X31  ...
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Class II Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. Edward Lifesciences, Llc
Devices Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill. C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03 Class III Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications. Pointe Scientific, Inc.
Biologics Red Blood Cells Leukocytes Reduced W087615570309; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Virginia Blood Services
Biologics Red Blood Cells Leukocytes Reduced W051515030543; W051514083443; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Innovative Blood Resources
Devices MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic. Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07 Class II Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end. MedtestDx, Inc.
Devices Injector, Angiographic; Medrad® Mark 7 Arterion® Injection System; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies. Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009,  ...
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Class II Certain Medrad® Mark 7 Arterion® Injection Systems, which utilize Software Version SW 005.006_SH, have a potential situation involving the purge enforcement procedure. This recent software revision has resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. No injuries reported. Bayer Healthcare
Devices Merlin@home RF Remote Monitoring Transmitter Model EX1150. Intended to aid in the remote support of SJM implantable pacemakers and ICD's. 0001 25140005 25140006 25140012 25140013 25140019 25140022 25140024 25140027 25140031 25140032 25140038 25140039 25140040 25140041 25140042 25140043 25140044 25140047 25140048 25140049 25140050 25140051 25140052 25140055 25140056 25140057 25140058 25140062 25140063 25140064 25140066 25140069 25140071 25140072 25140073 25140076 25140077 25140079 25140083 25140086 25140089 25140090 25140091 25140093 25140096 25140099 25140100 25140104 25140105 25140107 25140109 25140110 25140115 25140118 25140120 25140121 25140123 25140125 25140126 25140128 25140130 25140132 25140133 25140135 25140140 25140141 25140142 25140143 25140150 25140153 25140155 25140159 25140160 25140161 25140162 25140163 25140164 25140165 25140166 25140167 25140168 25140169 25140170 25140171 25140172 25140173 25140174 25140175 25140176 25140177 25140178 25140179 25140181 25140182 25140184 25140187 25140190 25140191 25140195 25140199 25140202 25140204 25140206 25140207 25140215 25140217 25140218 25140219 25140225 25140226 25140227 25140228 25140238 25140240 25140242 25140243 25140247 25140249 25140251 25140252 25140255 25140257 25140258 25140260 25140263 25140266 25140268 25140274 25140276 25140277 25140278 25140279 25140280 25140281 25140283 25140285 25140288 25140289 25140290 25140297 25140298 25140302 25140303 25140304 25140305 25140307 25140308 25140310 25140312 25140314 25140316 25140320 25140321 25140327 25140329 25140334 25140340 25140346 25140350 25140351 25140356 25140357 25140360 25140363 25140366 25140369 25140370 25140372 25140374 25140377 25140378 25140379 25140380 25140381 25140383 25140387 25140389 25140390 25140397 25140398 25140399 25140402 25140403 25140404 25140407 25140409 25140410 25140411 25140412 25140414 25140418 25140420 25140422 25140427 25140428 25140430 25140432 25140437 25140442 25140443 25140444 25140448 25140450 25140451 25140452 25140457 25140459 25140460 25140462 25140463 25140467 25140468 25140469 25140470 25140473 25140475 25140478 25140479 25140481 25140482 25140483 25140484 25140487 25140488 25140490 25140491 25140492 25140496 25140499 25140500 25140501 25140502 25140504 25140505 25140506 25140507 25140517 25140518 25140520 25140521 25140522 25140523 25140524 25140527 25140528 25140530 25140533 25140534 25140538 25140539 25140545 25140546 25140549 25140551 25140552 25140556 25140558 25140561 25140563 25140564 25140566 25140568 25140571 25140572 25140578 25140579 25140581 25140586 25140587 25140588 25140600 25140605 25140606 25140607 25140608 25140609 25140611 25140615 25140617 25140622 25140623 25140624 25140626 25140630 25140636 25140639 25140643 25140644 25140646 25140647 25140649 25140655 25140656 25140658 25140662 25140668 25140670 25140671 25140674 25140678 25140680 25140681 25140687 25140690 25140692 25140693 25140695 25140696 25140699 25140700 25140703 25140706 25140709 25140710 25140711 25140714 25140717 25140720 25140722 25140724 25140725 25140726 25140727 25140728 25140729 25140730 25140733 25140735 25140736 25140737 25140739 25140742 25140744 25140747 25140748 25140750 25140753 25140755 25140757 25140758 25140760 25140761 25140766 25140767 25140769 25140770 25140772 25140775 25140776 25140777 25140779 25140781 25140783 25140790 25140793 25140796 25140800 25140801 25140803 25140806 25140809 25140816 25140817 25140818 25140819 25140820 25140822 25140824 25140826 25140827 25140830 25140831 25140832 25140834 25140836 25140843 25140844 25140848 25140851 25140855 25140856 25140860 25140861 25140862 25140863 25140864 25140865 25140866 25140871 25140873 25140875 25140876 25140880 25140881 25140882 25140883 25140885 25140886 25140887 2514 Class II St. Jude Medical is recalling Merlin@home RF Remote Monitoring Transmitter Model EX1150 due to some devices exhibiting backup VVI operation due to a backup reset. St Jude Medical Cardiac Rhythm Management Division
Drugs Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5 Lot #s: a) KP9749, KT3501, Exp 09/2015, KP4524, Exp 11/2015, KV8264, Exp 01/2016, KX8713, KX8714, KX8715, Exp 04/2016; b) KP4525, Exp 11/2015, KP9750, Exp 12/2015, KX8716, Exp 04/2016 Class II Failed Stability Specifications: product may not meet specification limit for assay test. Apotex Inc.
Devices UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. Model # MUCC1C LOT # 1186054 Class II MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only. Biomet 3i, LLC
Biologics Platelets Pheresis Leukocytes Reduced W398515053678W; W398515053678W; W398515047330; W398515047330; W398515047330; W398515053678W; Class II Blood products, in which component preparations were not prepared in accordance with specifications, were distributed. Community Blood Center of Carolinas
Biologics Platelets Pheresis Leukocytes Reduced W050915037700; Class II Blood product, which tested positive for CMV, but was labeled as CMV-negative, was distributed. HCSC-Blood Center
Devices NICO Myriad Console Model number NN-7000 The Myriad System is a surgical system specifically designed for morcellation of soft tissue. It primarily consists of a reusable console with foot pedal and a disposable handpiece. For the morcellation and removal of tissue during pelviscopic, laparoscopic, percutaneous and open surgical procedures whenever access to the surgical site is limited. Model number NN-7000 SN: 00231, 00232, 00242, 00245, 00248, 00250 Class II Two specific cables within the console were inadvertently twisted during manufacturing. This twisting may result in the individual wires within the cables breaking and/or contacting one another where the cables terminate into two specific connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. Of the various types of malfunction, one may result in a potential health risk. Aspiration could increase unexpectedly. Nico Corp.
Devices XGAUZE Trauma Dressing, catalog number FIN-0002-01. XGAUZE is a 3" x 36" z-folded rayon/polyester dressing embedded with individual compressed cellulose sponges. Upon contact with blood or exudate, the sponges expand, thus increasing the dressing's capacity to absorb fluids. XGAUZE is packed in a pre-formed sterile barrier system (pouch sealed on three sides); one side is a PET/foil/PE film, and the other side is a PET/aluminum oxide/PE film. Packages are vacuum sealed and terminally sterilized via gamma radiation. Lot ESO54391, Expiration Date 9/25/2020; Lot ESO54725, Expiration Date 3/18/2020; Lot ESO54726, Expiration Date 3/30/2020; Lot ESO54741, Expiration Date 4/6/2020; Lot ESO54742, Expiration Date 4/13/2020; Lot ESO54743, Expiration Date 4/16/2020; Lot ESO54744, Expiration Date 4/23/2020; Class II The XGAUZE Trauma Dressing was recalled because the packages may acquire small tears or pinholes during shipping due to use of shipping containers that lacked adequate protective materials. If present, these small tears or pinholes may disrupt package integrity and render the device unsterile. Revmedx Inc
Biologics Red Blood Cells Leukocytes Reduced W044715137651; Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Rex Hospital, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W158015701606; Class II Blood product, collected using equipment that was not validated, was distributed. ARUP Laboratories, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W158015701463; Class II Blood product, collected using equipment that was not validated, was distributed. ARUP Laboratories, Inc.
Food Dry Grated Romano, Tipico Item #1-00111000, Net Wt. 50 lbs. Tipico Item#: 1-00111000. Lot # 15188 Exp: January 3, 2016 Class I Health risk because of listeria monocytogenes Tipico Products Company, Inc.
Biologics Red Blood Cells W0420150071615; Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Systems, Inc. DBA United Blood Services
Food Trader Joe's Dark Chocolate covered Honey Grahams with Sea Salt NET Wt. 8oz. (227g) SKU #0055 0246 Product is packaged in 8oz. clear tubs. UPC #00550246 "Best By" Dates 16 Mar 2016, 17 Mar 2016, 18 Mar 2016, 19 Mar 2016, 20 Mar 2016, 21 Mar 2016, 22 Mar 2016, 30 Mar 2016, 03  ...
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Class I Jo's Candies, LLC is recalling Trader Joe's Dark Chocolate covered Honey Grahams with Sea Salt because of undeclared milk. Jo'S Candies
Food Jansal Valley brand Raw Macadamia Nuts, packaged in 1 lb and 8 oz. plastic bags Lot code 469566. Class I Product contaminated with Salmonella Friendly Fruit, Inc. dba Sid Wainer & Son
Devices Boston Scientific, WATCHMAN® Left Atrial Appendage Closure Device with Delivery System, 21mm x 12F ( M635WU21060, WU21060, 24mm x 12F(M635WU24060, WU2406) , 27mm x 12F(M635WU27060, WU2706) , 30mm x 12F(M635WU30060, WU3006) , 33mm x 12F( M635WU33060, WU3306). 16752208 16891755 17138030 17211903 17214753 17296669 17395755 17483898 17712231 18053939 18120336 F00541702 F00541703 F00541707 F00541708 F00541709 F00541903 F00541904 F00541905 F00541906 F00541907 F00541908 F00541909 F00541913 F00541914 F00541916 F00544503 F00544504 F00544505 F00544508 F00544509 F00544511 F00544703 F00544704 F00544706 F00544707 F00544709 F00544710 F00545201 F00547501 F00547502 F00547505 F00547506 F00547507 F00547508 F00547509 F00547510 F00547511 F00547512 F00547514  ...
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Class II BSC has determined cross-threading of the hemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired. This Field Correction reinforces existing Directions for Use (DFU) and provides further guidance regarding the correct use of the hemostasis valve in order to avoid cross-threading and to securely seal the valve, minimizing the potential for undesirable blood leakage. Boston Scientific Corporation
Devices Boston Scientific, WATCHMAN® Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). 15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689 15746782 15711284 15753133 15757057 15760114 15764019 15767450 15768507 15770114 15772280 16635566 16691146 17148680 17628922 16675497 16723382 16731675 16738582 16740109 16752661 16760782 16880335 16897923 16904754 16751834 16893570 16894795 16933430 16937185 16940509 16943256 17038874 17041892 17044130 17046074 17123055 17126755 17127496  ...
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Class II BSC has determined cross-threading of the hemostasis valve may occur if the valve is tightened with the dilator in place, potentially preventing subsequent sealing of the valve when desired. This Field Correction reinforces existing Directions for Use (DFU) and provides further guidance regarding the correct use of the hemostasis valve in order to avoid cross-threading and to securely seal the valve, minimizing the potential for undesirable blood leakage. Boston Scientific Corporation
Devices Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone All lots, Model Number of device: 2090-0501, 2090-0502, 2090-0504, 2090-0505 Class II Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration Orthovita, Inc., dBA Stryker Orthobiologics.
Biologics Source Plasma DF0281336; Class II Blood product, collected from a donor who did not have a complete physical examination, was distributed. BPL Plasma, Inc.
Biologics Source Plasma DF0324896; Class III Blood product, collected from a donor in which there was no documentation of an arm or mouth inspection, was distributed. BPL Plasma, Inc.
Devices ACUSON SC2000 Ultrasound System with software versions VB10B and lower; Model 10433816; Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Model 10433816: Serial numbers: 400217 400290 400425 400439 400441 400443 400447 401496 401719 402310 402495 400308 400641 400770 401110 401114 401135 401136 401138 401169 401174 401176 401370 401406 401366 401460 401591 401750 401753 401793 401803 402090 402139 402177 402197 402255 402323 402327 402339 402351 402387 402492 402508 400261 400350 400763  ...
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Class II The ACUSON SC2000 ultrasound system considers uppercase/lowercase differences in the same patient name as unique patient instances when registered on the same ultrasound system. If these differences are not corrected at the time of registration, the system does not capture images or clips. Siemens Medical Solutions USA, Inc.
Devices Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene oxide The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution is employed. Lot 759491A Class II Medivators has identified Hemocor HPH700 High Performance Hemoconcentrators, Lot 759491A, may exhibit low ultrafiltration performance that is below product specification. Medivators, Inc.
Devices Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures. serial numbers: 5K0005, 5K0006, 5K0007, 5K0009, 5K0010, 5K0011, 5K0012, 5K0013, 5K0014, 5K0015, 5K0016, 5K0017, 5K0018, 5K0019, 5K0020, 5K0021, 5K0022, 5K0023, 5K0024, 5K0025, 5K0026, 5K0027, 5K0028, 5K0029, 5K0030, 5K0031, 5K0032, 5K0033, 5K0034, 5K0035, 5K0036, 5K0037, 5K0039, 5K0040, 5K0041, 5K0042, 5K0043, 5K0044, 5K0045, 5K0046, 5K0047, 5K0048, 5K0053, 5K0054, 5K0056, 5K0057, 5K0058, 5K0059,  ...
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Class II Medtronic has identified an issue with a USB memory component contained within a subset of CryoConsoles. The issue can result in extended procedure time. Medtronic Inc. Cardiac Rhythm Disease Management
Biologics Russian Thistle B15021704; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Fescue, Meadow B15021706; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Bermuda Grass B15021707; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Rye, Cultivated B15021705; B15021001; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Insects (Whole Body), Mite Dermatophagoides farinae B15021702; B15021002; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Insects (Whole Body), Mite Dermatophagoides pteronyssinus B15021703; B15021003; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Biologics Standardized Cat Hair B15021701; B150232; Class III Misbranded allergenic extracts were distributed. Allermed Laboratories Inc
Devices Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-02, 950156-03. Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301. Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902. Product number 950156-03: Lot numbers : NQ144001 NQ150501 NQ143902 NQ150601 NQ143901 NQ150602 NQ143803 NQ150703 NQ143601 NQ150701 NQ143602 NQ150702 NQ144502 NQ150801 NQ144801 NQ150901 NQ145202 NQ150802 NQ144901 NQ151001 NQ145301 NQ151002 NQ145201 NQ151101 NQ150301 NQ150501 NQ144001. Class II Internal investigation found that B. Braun 2 gang 4-way stopcocks provided within the Fluorescence Imaging Procedure Kit may experience damage to the sterile packaging during shipping. The damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks. Intuitive Surgical, Inc.
Drugs ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7. Lot #: 233169, Exp 02/16 Class III Chemical Contamination: impurity failure due to chemical contamination of the active ingredient. EMD Serono, Inc.
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