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U.S. Department of Health and Human Services

Enforcement Report - Week of February 3, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Veterinary "ABADY HIGHEST QUALITY MAINTENANCE & GROWTH FORMULA FOR CATS" packed in a cardboard retail box with white label with color printing attached to the exterior of the box. Lot code is stamped on the box. Product was provided in 3 pack sizes: NET WT. 2 lbs. (0.9 kgs.)***PRODUCT No. 201-02. NET WT. 5 lbs (2.27 kgs.)***PRODUCT No. 201-05. NET WT. 15 lbs (6.81 kgs.)***PRODUCT No. 201-15. 14029/21 Class I The Robert Abady Dog Food Co., LLC of Poughkeepsie, NY, is recalling its 2 lb, 5 lb & 15 lb boxes of "Abady Highest Quality Maintenance & Growth Formula for Cats" because they have the potential to be contaminated with Salmonella. The Robert Abady Dog & Cat Food Co / Nutra-Vet Research Co
Veterinary BRAVO! Raw Food Diet TURKEY BLEND FOR DOGS AND CATS; Product Number: 31-102; Size: 2 lb. (32 OZ) plastic tubes, UPC: 829546311025; Keep Frozen Best used by date: 11-05-15 Class I Product has the potential to be contaminated with Salmonella. BRAVO! LLC
Veterinary Bravo! Blends All Natural Chicken Blend diet for dogs & cats; Product Number: 21-102; Size: 2 lb. (32 OZ) plastic tubes - UPC: 829546211028 and Product Number: 21-105 Size: 5 lb. (80 OZ) 2.3KG plastic tubes - UPC: 829546211059; Keep Frozen. Best used by date: 08-11-16 Class I Product has the potential to be contaminated with Salmonella. BRAVO! LLC
Veterinary Premium Turkey Formula BRAVO Balance RAW DIET Product Number: 31-405; Size: 5 lb. (80 OZ) 2.3KG plastic tubes - UPC: 829546314057, Keep Frozen Best used by date: 11-05-15 Class I Product has the potential to be contaminated with Salmonella. BRAVO! LLC
Veterinary EVO Grain Free Turkey & Chicken Formula Cat & Kitten Food, packaged in 15.4 lbs. paper bags, UPC 5148 541400, Manufactured by Natura Pet Products, Inc., Fremont, NE; (1) Lot 4300A700D2; (2) Lots 4301A700A4, 4301A700B4, and 4301A700C4; (3) Lot 4300A700D3; Class I Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals. Mars Petcare USA
Veterinary California Natural Herring & Sweet Potato Formula, Adult Cat Food, packaged in 15 lbs paper boxes, UPC 5148 582357, Manufactured by Natura Pet Products, Inc., Fremont, NE. Lot 4307A700D2; Class I Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals. Mars Petcare USA
Veterinary EVO Grain Free Turkey & Chicken Formula Ferret Food, packaged in 6.6 lbs. paper bags, UPC 5148 542101, Manufactured by Natura Pet Products, Inc., Fremont, NE; Lots 4300A700D3 and 4307A700D3; Class I Batches of cat and ferret food were manufactured with no added vitamins and double the specified minerals. Mars Petcare USA
Veterinary Brand name: Barkworthies All Natural Chicken Vittles (Chicken neck) UPC: 8-16807-01151-0 SKU: BARK-ChicVit1lbc6 BEST BY: 05/2016 LOT: 1254T1 Net weight: 16oz. per bag, 6 bags per case Class I Feed Sample Report from the Colorado Department of Agriculture found Salmonella detected in Barkworthies All Natural Chicken Vittles (Lot 1254T1). TDBBS
Veterinary Bulk SP06193 Covance Rabbit 16 Feed Product Code: 207052 Class I A single lot of custom-produced, bulk rabbit feed was delivered by truck to a single customer. Flaked corn was inadvertently mixed with the rabbit feed. The sudden change in starch in the rabbit feed caused the death of less than 0.3% of population Cargill Feed and Nutrition
Veterinary DuMor Sheep Formula Net WT 50 lb (22.67kg) Item # 0047317; Formula No.: 55 ea; Lot Number 4NOV28LCK1. 50 lb bag' 40 paper bags/pallet. Class I Potential Copper Toxicity in the sheep feed lot. Land O Lakes Purina LLC
Devices Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu Model Number: 60-A0001; ZA05002 , ZA05003 , ZA05004  ...
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Class II Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message. Midmark Corp dba Progeny Inc
Veterinary 5C's DRYING LLC Cranberry Pomace, 1700 lbs plastic bag, Manufactured by 5C's Drying, LLC 09960 Rosedale Rd. Hicksville, Ohio 43526 Lot #66 Class I The firm was notified by their customer that the product test positive for Salmonella. 5Cs Drying LLC
Veterinary Nylabone Puppy Starter Kit Net Wt. 1.69 oz (48 g)Nylabone Products, PO Box 427 Neptune, NJ 07754-0427 UPC 0-1821481291-3 Lot #21935 Class I Nylabone Puppy Starter Kit may be contaminated with Salmonella. TFH Publications, Inc./Nylabone Products
Veterinary Blue Seal Home Fresh Starter Amp Medicated, 0.0125% Amprolium (113.5 g/ton), Manufactured by Kent Nutrition Group, Inc. General Offices Muscatine, Iowa 52761 Lot: 1015072 Class I A batch of poultry feed was assayed at 3.5% salt (above specification). Kent Nutrtion Group Inc
Veterinary OC Raw Dog Turkey & Produce Raw Frozen Formulation 6.5 lbs./2.95 Kg and bulk bags Product is raw and frozen, and packaged in plastic bags. lot 1511 USE BY 100815 Class I OC Raw Dog, LLC is initiating a recall of OC Raw Dog Turkey & Produce in 6.5 lb and bulk bags due to potential Salmonella contamination. oc Raw Dog
Veterinary Boulder Dog Food Company, L.L.C. Chicken Sprinkles, 3 Ounces, Single packages, with each package 8 x 5. Lot # 998, Best By 05/04/16 Class I Boulder Dog Food Company is recalling Chicken Sprinkles with Best by Date of 05/04/2016 because it tested positive for Salmonella. Boulder Dog Food Company, L.L.C.
Veterinary Boulder Dog Food Company,Gourmet Dog Treats Turkey Sprinkles Food Enhancer, Net Wt. 3 oz (85G), 100% Turkey Best By date of 05/18/16, 05/28/2016 and 05/30/2016, a Lot Number of 743, and a UPC Code of 899883001224 Class I Boulder Dog Food Company is recalling Chicken Sprinkles with Best by Date of 05/04/2016 and Turkey Sprinkles with Best by Date of 5/30/2016 because of the potential for Salmonella contamination. Boulder Dog Food Company, L.L.C.
Veterinary Nature's Variety Instinct Raw Chicken Formula Bites Nutrition for Dogs, packaged in 4 lb. plastic bags Net Wt. 4.0 LB (1.8 kg), UPC 7 6994961143 1, 6 (4 lb. bags) per case (UPC 7 69949 71143 8) and 7 lb. plastic bags Net Wt. 7.0 LB (3.2 kg), UPC 7 69949 61144 8, 4 (7 lb. bags) per case (UPC 7 69949 71144 5) . The responsible firm name on the label is Nature's Variety, Saint Louis, MO 63146. Best By 04/27/16 Class I Product tested positive for Salmonella Nature's Variety
Veterinary Nature's Variety Instinct Raw Chicken Formula Patties Nutrition for Dogs, packaged in 6 lb. plastic bags Net Wt. 6.0 LB (2.7 kg), UPC 7 6994961148 6, 6 (6 lb. bags) per case (UPC 7 69949 71148 3). The responsible firm name on the label is Nature's Variety, Saint Louis, MO 63146. Best By 04/27/16 Class I Product tested positive for Salmonella Nature's Variety
Veterinary Custom blended horse feed, packaged in 50 lb bags and in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Custom blended dairy feed, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Custom blended beef cattle feed, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Custom blended beef cattle feed, medicated, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Custom blended goat feed, medicated, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Custom blended goat feed, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary Corn, packaged in bulk None Class I Various feeds including horse feed were found to be contaminated with monensin Spring Creek Milling Co-op Inc.
Veterinary The Natural Dog Company, 12 Tremenda Sticks, 12oz, Resealable plastic bags All products not containing a lot number. Class I The Natural Dog Company is recalling 12 Tremenda Sticks due to potential Salmonella. Natural Dog Company, Inc.
Drugs Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Subpotent drug. Pharmakon Pharmaceuticals
Drugs Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Subpotent drug. Pharmakon Pharmaceuticals
Drugs Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 1 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc. All lots with expiration dates up to 11/17/2015 Class II Stability data does not support expiry. Pharmakon Pharmaceuticals
Drugs MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 18-Sep-15, 20-Sep-15, 21-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15 b) 16-Sep-15, 19-Sep-15, 21-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in 7.3ML Syringes, c) 380MG in 7.6ML Syringes, d) 400MG in 8ML Syringes, e) 460MG in 9.2ML Syringes, f) 475MG in 9.5ML Syringes, g) 500MG in 10ML Syringes, h) 580MG in 116ML Homepumps, i) 600MG in 120ML Homepumps, j) 650MG in 13ML Syringes, k) 800MG in 40ML Homepumps, l) 950MG in 19 mL Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 24-Sep-15, b) 24-Sep-15, 27-Sep-15, c) 26-Sep-15, d) 24-Sep-15, e) 27-Sep-15, f) 26-Sep-15, 27-Sept-15, g) 24-Sep-15, h) 26-Sep-15, i) 27-Sep-15, j) 26-Sep-15, k) 21-Sep-15 l) 24-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9% 218ML Homepumps, c) 0.45% in 500ML Homepumps, d) 0.9% in 500ML Homepumps, e) 0.9% in 1500ML Homepumps, f) 0.45% in 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15, 1-Oct-15, b) 22-Sep-15, c) 30-Sep-15 d) 29-Sep-15, e) 25-Sep-15, f) 28-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML Homepumps, c) 1140ML Homepumps, d) 1152ML Homepumps, e) 1400ML Homepumps, f) 1440ML Homepumps, g) 1500ML Homepumps, h) 1700ML Homepumps, i) 1900ML Homepumps, j) 2130ML Homepumps, k) 2250ML Homepumps, l) 2400ML Homepumps, m) 2650ML Homepumps, n) 2700ML Homepumps, o) 3250ML Homepumps, p) 3390ML Homepumps, and q) 3500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, b) 16-Sep-15 c) 25-Sep-15, d) 25-Sep-15 e) 20-Sep-15, 26-Sep-15, f) 20-Sep-15, 24-Sep-15, g) 20-Sep-15, 26-Sep-15, h) 20-Sep-15, i) 15-Sep-15, j) 26-Sep-15, k) 25-Sep-15, 26-Sep-15, l) 20-Sep-15, 23-Sep-15, m) 20-Sept-15, 24-Sep-15, 26-Sep-15, n) 23-Sep-15, o) 20-Sep-15, p) 26-Sep-15, q) 20-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c) 1GM in 50ML Homepumps, d) 2GM in 100ML Homepumps, and e) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 28-Sep-15, 29-Sep-15, c) 30-Sep-15 d) 28-Sep-15, 1-Oct-15 e) 25-Sep-15, 28-Sep-15, 29-Sep-15, 30-Sep-15,1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100ML Homepumps, c) 92MG in 115ML Homepumps, d) 104MG in 130ML Homepumps, e) 112MG in 140ML Homepumps, f) 120MG in 150ML Homepumps, g) 124MG in 155ML Homepumps, h) 128MG in 160ML, i) 136MG in 170ML Homepumps, j) 144MG in 180ML Homepumps, k) 152MG in 190ML Homepumps, l) 160MG in 200ML Homepumps, m) 172MG in 215ML Homepumps, n) 176MG in 220ML Homepumps, and o) 200MG in 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 29-Sep-15, c) 25-Sep-15, 30-Sep-15, d) 25-Sep-15, e) 1-Oct-15, f) 29-Sep-15, g) 26-Sep-15, h) 1-Oct-15, i) 29-Sep-15, j) 25-Sep-15, k) 1-Oct-15, l) 25-Sep-15, m) 27-Sep-15, 1-Oct-15, n) 24-Sep-15, 30-Sep-15, o) 25-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 22-Sep-15, 23-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps, c) 1800ML Homepumps, d) 2000ML Homepumps e) 2350ML Homepumps, and f) 2800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 20-Sep-15, c) 24-Sep-15, d) 20-Sep-15, e) 24-Sep-15, f) 26-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homepumps and b) 160 mEq KCL/LITER 500ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML Homepumps, and c) 1920ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15, c) 28-Sep-15, 1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 8GM in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 26-Sep-15, 27-Sep-15, b) 21-Sep-15, 24-Sep-15, 25-Sep-15, 26-Sep-15, 27-Sep-15, c) 25-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG in 380ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML Homepumps, c) 850MG in 170ML Homepumps, d) 1GM in 200ML Homepumps, e) 1.25GM in 250ML Homepumps, f) 1.5GM in 300ML Homepumps, g) 1.75GM in 350ML Homepumps, h) 2GM in 400ML Homepumps, i) 4000MG in 800ML Homepumps, j) 5000MG in 1000ML Homepumps, k) 6GM in 1200ML Homepumps, l) 7.5GM in 1500ML Homepumps, and m) 9000MG in 1800ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15, 30-Sep-15, b) 25-Sep-15, 29-Sep-15, c) 25-Sep-15 d) 25-Sep-15, 26-Sep-15, 29-Sep-15, e) 25-Sep-15, 1-Oct-15, f) 28-Sep-15, 29-Sep-15, 1-Oct-15, g) 25-Sep-15, h) 25-Sep-15, 27-Sep-15, 29-Sep-15, i) 29-Sep-15, j) 25-Sep-15, 26-Sep-15, k) 29-Sep-15, l) 25-Sep-15, 27-Sep-15, 30-Sep-15, m) 1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 25-Sep-15, 28-Sep-15, 29-Sep-15, 1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Homepumps, c) 125MG in 125ML Homepumps, d) 250MG in 125ML Homepumps, e) 135MG in 135ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 29-Sep-15 b) 30-Sep-15 c) 1-Oct-15, d) 30-Sep-15, e) 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 488ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, 1-Oct-15, b) 28-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML Homepumps and b) 1 GM in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 22-Sep-15, b) 19-Sep-15, 20-Sep-15, 22-Sep-15, 23-Sep-15, 24-Sep-15, 25-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c) 12GM in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15, b) 30-Sep-15, 1-Oct-15, c) 28-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepumps, b) 4.5GM in 100ML Homepumps, c) 18GM in 267ML Homepumps, d) 27GM in 400ML Homepumps, and e) 36GM in 533ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 1-Oct-15 b) 28-Sep-15 c) 25-Sep-15, 29-Sep-15, d) 26-Sep-15, 29-Sep-15 e) 1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 25-Sep-15, b) 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 27-Sep-15, b) 28-Sep-15, 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 25-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 17-Sep-15, 19-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 27-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c) 3600ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 28-Sep-15 b) 14-Sept-15 c) 1-Oct-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 28-Sep-15, 30-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 29-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiry: 28-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Drugs MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA RX, 535 Independence Pkwy ste.300, Chesapeake, VA 23320-5176. All Lots compounded between 11-Sep-15 and 17-Sep-15. Expiries: 24-Sep-15, 27-Sep-15 Class II Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Sentara Enterprises
Devices Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile. Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020. Class II The cannulae may bend during procedure. Globalmed Logistix
Devices Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111 All lot numbers Class II The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill). Fresenius Medical Care Renal Therapies Group, LLC
Devices D-10 Rack Loader; Model Number 220-0600; Hematology: The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection, and analysis. All codes - 2006 to present Class II On a rare occasion, there is a potential to assign a patient result to an incorrect sample ID when running in D10 Rack Loader configuration. Bio-Rad Laboratories, Inc.
Food Mandarin Oranges (In Light Syrup), Net Wt. 8oz (227g), Case UPC#: 100-49022-80895-6, Product UPC#: 0-49022-80895-9 Lot numbers: H894K09A 01/11/2017 4200/01039 01/16/2018 4200/01039 02/01/2018 Class II MW Polar Foods is recalling Mandarin Oranges due to possible glass in product. Milky Way Intl Trading Corp
Devices ZilverĀ® 518RX Vascular Stent with Rapid Exchange Delivery System Catalog number Lot number expiration date ZIVX5-18-125-10-20 CF997863 5/26/2017 ZIVX5-18-125-10-30 C914595 9/9/2016 ZIVX5-18-125-10-40 C1007990 6/13/2017 ZIVX5-18-125-10-40 C903747 7/15/2016 ZIVX5-18-125-10-40 C912971 8/9/2016 ZIVX5-18-125-10-40 C938554 11/26/2016 ZIVX5-18-125-10-40 C958545 2/22/2017 ZIVX5-18-125-10-60 C930526 10/11/2016 ZIVX5-18-125-6-20 C930162 10/2/2016 ZIVX5-18-125-6-30 C930479 10/22/2016 ZIVX5-18-125-6-30 C943304 11/21/2016 ZIVX5-18-125-6-30 C986202 4/9/2017 ZIVX5-18-125-6-40 C900610 7/3/2016 ZIVX5-18-125-6-60 C1002991 5/30/2017 ZIVX5-18-125-6-60 C930157 10/3/2016 ZIVX5-18-125-6-60 C942893 11/20/2016 ZIVX5-18-125-6-60 C983822 4/9/2017 ZIVX5-18-125-6-80 C1002236 5/26/2017 ZIVX5-18-125-6-80 C901151 7/17/2016 ZIVX5-18-125-6-80 C930158 10/9/2016 ZIVX5-18-125-6-80 C930472 10/2/2016 ZIVX5-18-125-6-80 C939542 11/15/2016 ZIVX5-18-125-7-20 C930531 10/21/2016 ZIVX5-18-125-7-30 C912970 8/14/2016 ZIVX5-18-125-7-30 C974746 3/5/2017 ZIVX5-18-125-7-40 C903763 7/15/2016 ZIVX5-18-125-7-40 C941308 11/18/2016 ZIVX5-18-125-7-60 C907738 8/14/2016 ZIVX5-18-125-7-60 C938264 11/15/2016 ZIVX5-18-125-7-80 C939549 11/15/2016 ZIVX5-18-125-7-80 C984606 4/16/2017 ZIVX5-18-125-7-80 C985048 4/16/2017 ZIVX5-18-125-7-80 C994597 5/1/2017 ZIVX5-18-125-8-20 C930525 10/21/2016 ZIVX5-18-125-8-30 C912967 8/9/2016 ZIVX5-18-125-8-30 C967899 2/27/2017 ZIVX5-18-125-8-40 C1001407 5/26/2017 ZIVX5-18-125-8-40 C912942 8/14/2016 ZIVX5-18-125-8-60 C942433 11/18/2016 ZIVX5-18-125-8-80 C939972 11/15/2016 ZIVX5-18-125-8-80 C983347 4/9/2017 ZIVX5-18-125-8-80 C994190 4/29/2017 ZIVX5-18-125-9-20 C939000 11/15/2016 ZIVX5-18-125-9-30 C939545 11/15/2016 ZIVX5-18-125-9-40 C939544 11/15/2016 Class II Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event. Cook Medical Incorporated
Devices EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250. Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016 Class II All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies. Phadia Ab
Drugs Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. a) Lot #: 199691, Expiry: 02/2016; Lot # 221481, Expiry: 03/2016, Lot #: 223921, Expiry: 05/2016; Lot #: 226211, Expiry: 06/2016; Lot #: 228611, Expiry: 08/2016; Lot #: 230711, Expiry: 09/2016; Lot #: 232591, Expiry: 11/2016; Lot #: 234551, Expiry: 12/2016; Lot #: 238871, Expiry: 01/2017; Lot #: 239801, Expiry:  ...
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Class III Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc.
Drugs Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64. Lot #:199001, Expiry: 01/2016; Lot #: 222591, Expiry: 04/2016; Lot #: 224491, Expiry: 06/2016; Lot #: 229241, Expiry: 08/2016; Lot #: 232941, Expiry: 11/2016; Lot #: 239921, Expiry: 02/2017; Lot #: 241701, Expiry: 04/2017; Lot #: 246851, Expiry: 07/2017. Class III Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc.
Drugs Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. a) Lot #: 232601, Expiry: 01/2016; Lot #: 233471,  ...
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Class III Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert. Bausch & Lomb, Inc.
Drugs Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26. Lot #s: 5MK0340, 5LK0592, Exp 08/17 Class II Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. Perrigo Company PLC
Drugs Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895. Lot #s: 5LK0528, 5LK0630, 5LK0779, Exp 03/17 Class II Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups. Perrigo Company PLC
Devices Fuse 1C Colonoscope Item number: FSC-3300-SL, Model number: C38s, Serial numbers: F1C0218FUSE1CS, F1C0219FUSE1CS, F1C0220FUSE1CS, F1C0221FUSE1CS, F1C0222FUSE1CS, F1C0223FUSE1CS, F1C0224FUSE1CS, F1C0225FUSE1CS, F1C0228FUSE1CS, F1C0229FUSE1CS, F1C0230FUSE1CS, F1C0231FUSE1CS, F1C0232FUSE1CS, F1C0233FUSE1CS, F1C0235FUSE1CS, F1C0236FUSE1CS, F1C0237FUSE1CS, F1C0238FUSE1CS, F1C0239FUSE1CS, F1C0241FUSE1CS, F1C0243FUSE1CS, F1C0245FUSE1CS, F1C0246FUSE1CS, F1C0247FUSE1CS, F1C0248FUSE1CS, F1C0249FUSE1CS, F1C0250FUSE1CS, F1C0251FUSE1CS, F1C0252FUSE1CS, F1C0253FUSE1CS, F1C0254FUSE1CS, F1C0255FUSE1CS, F1C0256FUSE1CS, F1C0257FUSE1CS, F1C0258FUSE1CS, F1C0259FUSE1CS, F1C0261FUSE1CS, F1C0262FUSE1CS, F1C0263FUSE1CS, F1C0264FUSE1CS, F1C0266FUSE1CS, F1C0267FUSE1CS,  ...
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Class II The bending section of the device may partially separate from the insertion tube. Potential for tissue trauma. EndoChoice, Inc.
Drugs Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. Lot # 151387, Exp 10/31/16 Class II Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Amerisource Health Services
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