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U.S. Department of Health and Human Services

Enforcement Report - Week of May 22, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Fresh Frozen Plasma (Apheresis) 71X52474 part 1 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Source Plasma 372096384; 372095334; 372094672; 372093645; 372093052; 372092045; 372090293; 372088790; 372088180; 372087073; 372086472; 372085212; 372084648; 372082085; 372081677; 372080542; 372077876; 372077265; 372075681; 372075140; 372073882; 372073290; 372071702; 372071102; 372069488; 372067904; 372067296; 372066247; 372065681; 372064593; 372063947; 372062884; 372062252; 372059770; 372059081; 372057615; 372056898; 372055988; 372055497; 372054548; 372053473; 372049013; 372048030 Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 4663295- part 1 & 2; 4663335- part 1 & 2; 4663316- part 1 &  ...
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Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated 4663294- part 1 & 2 Class II Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. Northwest Florida Blood Center, Inc.
Biologics Source Plasma 02IIAA7720 Class III Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells 6303489 Class III Blood product, collected from a donor whose arm inspection was not performed, was distributed. BloodNetUSA, Inc.
Biologics Blood and Blood Products for Reprocessing 6303489 Class III Blood product, collected from a donor whose arm inspection was not performed, was distributed. BloodNetUSA, Inc.
Biologics Red Blood Cells 25FG53377; 25FR30134; Class II Blood products, collected from a deferred donor, were distributed. American National Red Cross (The)
Biologics Platelets 25FR30134; 25KK27769 Class II Blood products, collected from a deferred donor, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 4503686 Class II Blood products, collected from a donor who was previously deferred for being at increased risk for vCJD, were distributed. The Blood Alliance, Inc.
Biologics Red Blood Cells Leukocytes Reduced Irradiated 021LE24198. Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Plasma Frozen 021LE24188, 021LM25906, 021LM25915, 021LM25918, 21LE24195, 021LE24211, 021LM25920. Class III Blood products, collected using expired blood collection sets, were distributed. American National Red Cross (The)
Biologics Red Blood Cell Leukocytes Reduced 021LM25919, 021LE24330, 021LE24332, 021LM25913, 021LM25917, 021LM25911, 021LM25914, 021LE24200, 021LE24187, 021LE24189, 021LE24329, 021LM25924, 021LE24331, 021LE24335, 021LE24338, 021LE24346, 021LM25906, 021LM25908, 021LM25915, 021LM25916, 021LM25918, 021LM25921, 021LM25922, 021LM25930, 021LM25932, 021LM25934, 021LE24214, 021LE24217, 021LE24188, 021LM25929, 21LE24345, 21LE24205, 021LE24191, 021LE24192, 021LE24349, 021LE24351, 021LE24352, 021LE24355, 021LE24209, 021LE24211, 021LE24216, 021LE24190, 021LE24207, 021LE24210, 021LE24343, 021LM25920, 21LE24213, 21LE24195, 21LE24188, 021LE24184,  ...
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Class III Expired Blood bags used. American National Red Cross (The)
Biologics Source Plasma JK0182128 Class II Blood products, collected from a donor who admitted to high risk behavior, were distributed. DCI Biologicals Orlando LLC
Biologics Source Plasma OL0107985; OL0108176; OL0108514; OL0108652; OL0109051 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. DCI Biologicals Orlando LLC
Biologics Blood and Blood Products for Reprocessing 20LQ15418 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 20LQ15418 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 6864613 Class III Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 6864613 Class II Blood products, collected from a donor who was previously deferred for positive HIV test results, were distributed. Community Blood Center of the Ozarks
Biologics Blood and Blood Products for Reprocessing 20FM43725 Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 20FM43725 Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 181799600, 184284750 Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed. Blood Systems Inc
Biologics Red Blood Cells Leukocytes Reduced 181799600, 184284750 Class II Blood products, collected from a donor who reported testing positive for hepatitis, were distributed. Blood Systems Inc
Biologics Platelets Pheresis Leukocytes Reduced 4573208A; 4573208C Class II Blood products, which did not meet the acceptable product specifications, were distributed. Florida Blood Services, Inc.
Biologics Source Plasma LR0305957; LR0306663 Class II Blood products, which were not quarantined subsequent to receiving information regarding post donation information, were distributed. DCI Biologicals Little Rock LLC
Biologics Source Plasma 366065365; 366065430; 366072465; 366074312; 366074666; 366081860; 366082295; 366083644; 366084122; 366088258; 366088678; 366090707; 366094116; 366094786; 366095612; 366096515; 366097322; 366098286; 366100123; 366100862; 366101853; 366102646; 366104664; 366104927; 366116229; 366120216; 366120573; 366121478; 366121828; 366123272; 377127087 Class II Blood products, collected from a donor who received a body piercing within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 366089959; 366089995 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Talecris Plasma Resources, Inc.
Food Hokkai Frozen Half Shell Oyster, 144 pcs/case. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Tiny Oyster Meat I.Q.F., 40x8 oz No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Medium/Large Size Oyster Meat I.Q.F., 4 lbs x 6. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Food Hokkai Large Size Oyster Meat I.Q.F., 1 lb x 20, 3 lbs x 8, 1 lb x 30. No codes. Class II The product has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. Hong Chang Corporation
Biologics Source Plasma Q19486, Q19487, Q19488, Q19490 Class III Blood products untested for HIV and HCV by NAT were distributed. Blood and Plasma Research, Inc.
Biologics Red Blood Cells Leukocytes Reduced W045008039358; W045008115056; W045009058101 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma W045008039358; W045008115056; W045009058101 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Platelets Pheresis Leukocytes Reduced W045006901629 Part 1;W045006901629 Part 2 Class II Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed. Community Blood Center Of Gtr KC
Biologics Source Plasma 5090011060 5090010338 5090019665 5090019435 5090017266 5090016755 5090016499 5090013137 5090012145 5090010621 5090009573 5090019647 5090019305 5090018810 5090018523 5090018545 5090017961 5090016116 5090025472 5090024995 5090023820 5090023303 5090017822 5090017009 5090016695 5090015129 5090014746 5090027102 5090026966 5090023844 5090023460 5090022964 5090021841 5090019671 5090019323 5090018846 5090018518 5090017967 5090017511 5090017149 5090015286 5090014719 5090014044 5090025510 5090025051 5090024528 5090024156 5090023662 5090023409 5090022849  ...
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Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Talecris Plasma Resources, Inc.
Biologics Source Plasma 0550714031; 0550707898; 0550703257; 0550701001; 0550700271; 0550642393; 0550840775; 0550839511; 0550838865; 0550837444; 0550836705; 0550832513; 0550831053; 0550830130; 0550827079; 0550824869; 0550824214; 0550822892; 0550822106; 0550817357; 0550815598; 0550814986; 0550813249; 0550812388; 0550810967; 0550810105; 0550807402; 0550806425; 0550804679; 0550797903; 0550795059; 0550794450; 0550787218; 0550786385; 0550719996; 0550706561; 0550705373; 0550703839; 0550702722; 0550701675; 0550700484; 0550699347; 0550698067; 0550697346; 0550695879; 0550695123; 0550693506; 0550692919; 0550552609; 0550547819;  ...
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Class II Blood products, collected from donors who were previously deferred, were distributed. CSL Plasma, Inc.
Devices Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36775, 36786, 36828, 36864 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36785, 36827 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36829 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36832 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36833 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36850 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36835 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36836 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36781 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36851 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36897 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Devices Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives). Lot 36815 Class II Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Karl Storz Endoscopy America Inc
Drugs a) Firminite 805 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.FIRMINITE.COM, b) Libidron 410 mg is packaged in 2 count, 4 count, and 10 count capsules blister packs in a box, WWW.LIBIDRON.COM , c)Extra Strength Instant Hot Rod 496 mg is packaged in 4 count and 10 count capsule blister packs in a box, www.HotRodExtraStrength.com All lots Class I Marketed Without an Approved NDA/ANDA: These products found to contain undeclared tadalafil. Tadalafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. InSo-Independent Contractor for West Coast Nutritionals,LTD
Drugs Mojo Nights, 1 capsule, UPC 7 18122 11983 7, Distributed By: Mojo Health Lauderhill, FL 33351 All lots, no Expiry Class I Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Evol Nutrition
Drugs Mojo Nights for Her, 1 capsule, UPC 7 18122 12133 5, Distributed By: Mojo Health Lauderhill, FL 33351 All lots no Expiry Class I Marketed Without an Approved NDA/ANDA: The products were found to contain FDA approved ingredients and analogues of FDA approved ingredients used to treat male erectile dysfunction, making them unapproved new drugs. Evol Nutrition
Biologics Red Blood Cells 11631200368800Q; Class II Blood product, collected from a therapeutic donor with polycythemia vera, was distributed Florida Blood Services, Inc.
Veterinary ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food, for Conures, Amazons, Greys, Pionus, Caiques, Senegals and other medium to large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags. Lot 598405052 UPC 762177830209, Exp date: 11/30/2013 (2 lbs package) UPC 762177830308, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177831206, Exp date: 11/30/2013 (12 lbs package) UPC 762177831701, Exp date: 11/13 (17.5 lbs package) UPC 762177833507, Exp date: 11/13 (35 lbs package) Class I The products contain elevated calcium levels. Premium Nutritional Products Inc
Veterinary ZuPreem FruitBlend with Natural Fruit Flavors, Premium Daily Bird Food for Macaws, Cockatoos, Amazons and other Large parrots. Packaged in 2 lb, 3.5 lb and 12 lb stand-up plastic pouches; also packaged in 17.5 lb and 35 lb bulk paper bags. Lot 598405072 UPC 762177840208, Exp date: 11/30/2013 (2 lbs package) UPC 762177840307, Exp date: 11/30/2013 (3.5 lbs package) UPC 762177841205, Exp date: 11/30/2013 (12 lbs package) UPC 76211841700, Exp date: 11/13 (17.5 lbs package) UPC 762177843506, Exp date: 11/13 (35 lbs package) Class I The products contain elevated calcium levels. Premium Nutritional Products Inc
Veterinary Dogsbutter RUC with Flax PB, 16 oz UPC 3050. Best-If-Used-By Dates between March 1, 2011 and September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Sunland Valencia Roasted and Blanched Wildlife, 30 lb UPC 41322. Best-If-Used-By Dates between March 1, 2011 and September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Sunland Raw Shelled Wildlife (not for human use), 50 lb item 402. Identified with Best By Dates March 1, 2011 through September 24, 2013. Class I Sunland, Inc. is conducting a voluntary limited recall of its Almond, Peanut, and Cashew Butter products and Tahini and Roasted Blanched Peanut Products, manufactured between May 1, 2010 and September 24, 2012, because these products may be contaminated with Salmonella. Sunland, Incorporated
Veterinary Dogcandy Holiday Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine, UPC 692614010041 Best By Date of 08/2015 UPC 692614010041 Class III The product has the potential to contain mold. Claudia's Canine Cuisine
Veterinary Dogcandy Blueberry Hound Cake 7.5 oz manufactured by Claudia's Canine Cuisine , UPC 692614010058 Best By Date of 08/2015 UPC 692614010058 Class III The product has the potential to contain mold. Claudia's Canine Cuisine
Drugs libigrow capsules, PERFORMANCE ENHANCER, supplied in 1, 5 and 10 count blister packs, Distributed By: H & K Nutraceuticals Los Angeles, CA 1 count blister: UPC 094922567611, 5 count blister: UPC 094922567628, 10 count blister: UPC 610585434253. 1 count blister: Lot#: 791115, Exp: 12/13; Lot#: 01M0111, Exp: 01/14; Lot#: 01M0212-1, Exp: 02/15; Lot# 01M0212, Exp: 02/15; Lot# 01M0611-2, Exp: 06/14, 5 count blister: Lot# 05M0412, Exp: 04/16, 10 count blister: Lot# 10M0412, Exp: 04/16. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs libigrow XXXTREME Capsules, MAXIMUM STRENGTH FORMULA, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By Kretek International, Inc. Moorpark, CA 930210 1 count blister: UPC 705105830735, 5 count blister: UPC 610585435939, 10 count blister: UPC 610585435922. 1 count blister: Lot# 01MNU0912, Exp: 09/15; Lot# 01X0412-1, Exp: 04/15; Lot# 021647, Exp: 12/13, 5 count blister: Lot# 05X0412, Exp: 04/16, 10 count blister: Lot# 10X0412, Exp: 04/16; Lot# 10M0111, Exp: 01/14. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs BLUE Diamond Pill, supplied in 1, 5 and 10 count blister packs, Male Sexual Enhancement, Distributed By: DH Distribution Los Angeles, CA 90026. 1 count blister: UPC 705105524764, 5 count blister: UPC 736211124012, 10 count blister: UPC 736211123916. 1 count blister: Lot# 01M0412, Exp: 04/15, and Lot#91782, Exp: 01/14. 5 count blister: Lot# 05M0412, Exp: 04/15; 10 count blister: Lot# 10M0412, Exp: 04/15. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs BLUE Diamond PLATINUM Capsules, 1000 mg, supplied in 1, 5 and 10 count blister packs, Distributed By: DH Distribution Los Angeles, CA 90026 1 count blister UPC -608641933543; 5 count blister UPC - 608641932867; 10 count UPC -608641933536 (1 count)Lot# 01MNU0912, Exp: 08/15, (5 count) Lot# 05BD0712, Exp: 07/15 and 121781, Exp 01/14; (10 count) Lot # 05BD0712, Exp: 07/15 Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Mojo nights Capsules, Male Sexual Enhancer, supplied in 1 and 5 count blister packs, Distributed By: Mojo Health, Pompano Beach, FL I count blister UPC - 718122119738; 5 count blister UPC - 705105836430; (1 count) Lot# 01MJ0712, (1 count) 01MM0211 Exp: 07/15; (5 count) Lot# 05M0912, Exp: 10/15; Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Mojo nights SUPREME Capsules, 1000 mg, Male Sexual Enhancer, supplied in 1 count blister packs, UPC 610585435915; Distributed By: Mojo Health, Pompano Beach, FL Lot# 01MJS0712, Exp 07/15. Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs CASANOVA Capsules, 450 mg, MALE SEXUAL ENHANCER, supplied i n1 count blister packs, UPC 736211906892; Distributed by: Casanova Distributors, Tucker, GA Lot# 030112, Exp: 03/15 Class I Marketed Without an Approved NDA/ANDA: product may contain undeclared sildenafil, tadalafil and analogues of these FDA approved active ingredients, making them unapproved drugs Performance Plus Marketing, Inc.
Drugs Methylprednisolone Preservative Free 40 mg/ml Injectible Suspension, 1 mL Vials and 2 mL Vials and 1 mL pre-filled syringes, For Office Use Only, Manufactured by Green Valley Drugs, Henderson, NV. Lot #s: 20121105-B, 20121112-G Class I Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. Green Valley Drugs
Drugs Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV. Lot: 20121126-H Class I Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV. Green Valley Drugs
Veterinary MoorMan's ShowTec 18 Elite Lamb DC medicated textured grain mix, packaged in 50 lb bags Lot BF23512 - manufactured 08/22/12 184 - 50lb bags produced for sale Lot BF27812 - manufactured 10/04/12 120 - 50lb bags produced for sale Lot BF29312 - manufactured 10/19/12 73 - 50lb bags produced for sale Class I ADM Alliance Nutrition of Bluffton, IN initiated a recall on 12/19/12 for 3 lots of MoorMans® ShowTec 18 Elite Lamb DC sold in 50 lb bags. The recall was initiated in response to a customer complaint stating that 2 of the customers sheep had died of copper toxicosis after consuming MoorMan's® ShowTec 18 Elite Lamb DC. ADM Alliance Nutrition, Inc.
Drugs Super Power capsules, Proprietary Blend 570 mg, packaged in 2-count capsules per blister pack, Distributed by: Freedom Trading, NJ 08863, UPC 7 18122 90678 9. Lot L08108, Exp 06/15 Class I Marketed Without An Approved NDA/ANDA: This dietary supplement has been found to contain sildenafil, an FDA approved drug for the treatment of male erectile dysfunction making this an unapproved new drug. D& S Herbals, LLC
Devices Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery. Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006. Class II Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter. Edwards Lifesciences, LLC
Drugs Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1. Lot #: B120217A, Exp 05/15 - US Distribution Class I Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection). Gilead Sciences, Inc.
Biologics Source Plasma UQ170193; UQ169364; UQ167981; UQ167387; Class II Blood products, collected from a donor who was previously deferred, were distributed. Plasma Biological Services Inc
Biologics Platelets Pheresis Leukocytes Reduced W120612021337 Part A; W120612021337 Part B Class II Blood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed. Michigan Blood
Biologics Platelets Pheresis Leukocytes Reduced W051512134136; Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. Memorial Blood Centers
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W051512077416; W051512077426; W051512077431; Class III Blood products, labeled with incorrect volume, were distributed. Memorial Blood Centers
Biologics Red Blood Cells Leukocytes Reduced Irradiated 1413206; Class II Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Memorial Blood Centers
Biologics Blood and Blood Products for Reprocessing 1413206; Class III Blood products, collected from a donor in whom donor suitability was not adequately determined, were distributed. Memorial Blood Centers
Biologics Plasma Frozen within 24 hours (FP24) 009KE30955; Class II Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced W038112201491; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Plasma Frozen W038112201491; Class II Blood products, collected from a donor who was previously deferred, were distributed. Florida's Blood Centers, Inc.
Biologics Source Plasma 0050349533; 0050350236; Class II Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed. Biomat USA, Inc
Veterinary Nature's Variety Instinct raw, Organic Chicken Formula medallions, packaged in 3-lb bags and packaged 9/3-lb bags/case. UPC # 7 69949 60137 1, 3-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70137 8, 27-lb case (9/3-lb bags/case) Best if Used By date of 10/04/13 Class I The products may contain hard plastic pieces. MI Industries Inc
Veterinary Nature's Variety Instinct raw, Organic Chicken Formula patties, packaged in 6-lb bags and packaged in 6/6-lb bag/cases. UPC # 7 69949 60127 2, 6-lb bag Best if Used By date of 10/04/13 UPC # 7 69949 70127 9, 36-lb case (6/6-lb bags/case) Best if Used By date of 10/04/13 Class I The products may contain hard plastic pieces. MI Industries Inc
Biologics Red Blood Cells Leukocytes Reduced W230811203265; Class II Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed. Coastal Bend Blood Center
Biologics Blood and Blood Products for Reprocessing W230811203265; Class II Blood products, which were not quarantined subsequent to receiving information regarding donor's deferral status, were distributed. Coastal Bend Blood Center
Devices REF 1103***HVAD Pump Implant Kit. Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675 Class II HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector. Heartware Inc
Biologics Bone 0092190096 Class II Human tissue allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P. University Of Miami Miller School of Medicine Tissue Bank
Devices QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook. Catalog Number 4503225, Lot #142345648, Exp: 06/09/14 & Lot #142357718 Exp: 06/09/14 Class II CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. QIAGEN Gaithersburg, Inc.
Devices QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG). Catalog Number 4503223, Lot #142345647, Exp: 06/09/14 Class II CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. QIAGEN Gaithersburg, Inc.
Food Adobo sin pimienta (Adobo without pepper) in 5 oz, 14 oz, and 32 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Adobo con pimienta (Adobo with pepper) in 5 oz, 14 oz, and 32 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazonador de Carnes (Meat Seasoning) in 5 oz, 14 oz, and 28 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazon Perfecta (Perfect Seasoning) in 4 oz, 12 oz, and 24 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Sazon Fajita (Fajita Seasoning) in 5 oz, 14 oz, and 28 oz No code dates. Firm recalling all product purchased between 3/1/2011 to 3/27/2013 Class I Undeclared allergen - Soy Lisy Corp.
Food Heartland Gourmet Gluten Free double chocolate cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lots 0022317 best buy date 10/2014, 012341 best buy date 01/2014, and 0012289 best buy date 10/2014 Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Food Heartland Gourmet Gluten Free chocolate chip cookie mix, DAIRY FREE, packaged in 16-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lot 023065, best buy date 12/2014 and Lot 0023007, best buy date 10/2014. Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Food Heartland Gourmet Gluten Free rosemary basil pizza crust mix, DAIRY FREE, packaged in 15.4-oz. boxes. Manufactured by: Heartland Gourmet, LLC, Lincoln, NE. Lot 073007 best buy date 09/2014 Class I Some of the products contain milk but are labeled as dairy free. Heartland Gourmet, LLC
Drugs Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244 Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014 Class II Lack of Assurance of Sterility; reports of adverse events after injection NuVision Pharmacy, Inc.
Devices Dural Graft Matrix DuraGen® Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.. 1125807, 1125802, 1125806, 1125804, 1125808, 1111845, 1125805, 1125803, 1125809, 1125810, 1130069, 1130061, 1130064, 1130065, 1130417, 1130521, 1110850, 1111839, 1111621, 1110274, 1105302, 1110669, 1111618, 1112228, 1110160, 1110670, 1111606, 1111616, 1104916, 1111614, 1111615, 1110273, 1111277, 1111849, 1110667, 1104918, 1110853, 1111619, 1111842, 1110666, 1112109, 1112108, 1104917, 1110854, 1111620, 1110276, 1105301, 1111846, 1112225, 1110851, 1111617, 1105303, 1110852, 1110270, 1105304, 1110246, 1112222, 1112224, 1110245, 1111844, 1111850, 1110668, 1125522, 1125628, 1104879, 1110814, 1111610, 1125525, 1104876, 1110815, 1111607, 1125526 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference. 1125682, 1125681 1125817, 1125983, 1126018 1126019, 1130641 1130642, 1110848, 1110849 1111883, 1111354, 1111884 1111936, 1112151 1110256, 1111355 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes. 1125523, 1125517 1125522, 1125539 1125524, 1125525 1125526, 1125632 1125630, 1125678 1125679 1125677, 1125683 1125628, 1125813 1125814, 1125815 1125629, 1125520 1125521, 1125979 1126031, 1125980 1125981, 1125982 1126030, 1130243 1130071, 1130503 1130379, 1130381 1130384, 1130507 1130374, 1130380 1130382, 1130421 1130505, 1130424 1130654, 1130422 1130423, 1130428 1130639, 1130413 1130414, 1130383 1130425, 1130504 1130506, 1130426 1130427, 1130970 1130827, 1111606 1104879, 1110814 1111610, 1104876 1110815, 1111607 1110268, 1111360 1112339, 1104405 1104877, 1105455 1112008, 1112110 1112111, 1110845 1111940, 1112149 1104880, 1112148 1110244, 1110265 1110846, 1104878 1111609, 1111941 1104881, 1110812, 1110267, 1111359, 1112340, 1105307, 1111611, 1111939, 1112341, 1110266 1112146, 1112147 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. 1125963, 1130387 1130386, 1130468 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. 1112107 1111938, 1112280, 1112038, 1111971 1112279, 1112104, 1112105 1112297, Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity. 1105457 1112377, 1112378 1112103 1112106, 1112003, 1112296, 1110715 1112052, 1112004, 1112030 1111972 1112376 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices INSTAT - Agent, Absorbable Hemostatic, Collagen Based INSTAT MCH is recommended for use in surgical procedures (other than Urological and Ophthalmological surgery) as an adjunct to hemostatis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1105177, 1105178 1110143, 1110227 1110228, 1110229 1110230, 1110233 1110786, 1110787 1111356, 1105179 111023 1, 1110232 1110785 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1104789 1104790, 1110793 1112248, 1110248 1111867 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. 1110788, 1112217 1110222, 1111357 1111602, 1105255 1110224, 1110225 1111601, 1110223 1110790, 1111603 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125130 ,1125686 1125687, 1125688 1126015, 1105298 1110145, 1110674 1111854, 1104502 1104503, 1105309 1105310, 1110249 1111366, 1111367 1111368, 1111370 1112262 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125684, 1125685 1125689, 1126014 1104963, 1110481 1110791, 1110792 1111363, 1111644 1110673, 1111856 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 1111151 1111152, 1111153 1111155, 1111156 1111157, 1111646 1105300 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1125414, 1126013 1130645, 1110250 1110251, 1110252 1111365, 1111878 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1104622, 1104962 1110241, 1110242 1110264, 1110783 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1126012, 1105396 1105397, 1105398 1105399, 1111364 1111641 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes. 1110144, 1110243 1110782, 1111645 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices OraMem Absorbable Collagen Membrane OraMem® Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1112066 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices BioMend® Extend" Absorbable Collagen Membrane BioMend® Extend" Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1104846, 1105175 1105253, 1110810 1110811, 1111149 1111859, 1104847 1105176, 1105254 1110809, 1111860 1104848, 1110819 1110820, 1111148 1111861 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as an adhesion barrier for the reduction of peridural fibrosis. 1125812 1125816 1126021 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices BioMend Absorbable Collagen Membrane BioMend® Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus. 1105251, 1105462, 1110805, 1110806, 1111144, 1110480, 1111145, 1111358, 1105392, 1110142, 1110807, 1111146, 1111362, 1111640, 1105252, 1105463, 1110808, 1111147, 1111865, 1110671, 1110672, 1111958, 1105393, 1111959, 1105394, 1110480, 1112022, 1105391 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices Absorbable Collagen Sponge Provided As Intermediate to Another Company 1130055, 1130057, 1130228, 1130229, 1130388, 1105192, 1110821, 1110822, 1110987, 1111023, 1112020, 1112379, 1104815, 1110841, 1110842, 1110843, 1110953, 1110954, 1111022, 1111821, 1105206, 1110844, 1110903, 1110904, 1110931, 1110932, 1112021, 1104791, 1104961, 1105174, 1105453, 1105454, 1110826, 1110827, 1110969, 1111159, 1111160, 1104710, 1110828, 1111158, 1111764 Class II Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products. Integra LifeSciences Corporation
Devices PROFILE-V MEDTOXScan Drugs of Abuse Test System. For the rapid, qualitative detection of drugs of abuse in human urine, Part No. 604018 - Lot No. 6821, 6822, 6823, 6824, 6825, 6831, 6832, 6841, 6851, 6852, 6853, 6861, 6862, 6863, 6864, 6865, 6866, 6867, 6868, 6871, 6881, 6891, 6892, 6901, 6902, 6903, 6904, 6911, 6912, 6921, 6922, 6931, 6942; Part  ...
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Class II Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory testing. Medtox Diagnostics Inc
Food Centerville Pie Company Clam Pie, 2 lb (Large) and 1 lb (Small) All codes Class I Undeclared allergen-anchovies Centerville Pie Company, Inc.
Drugs ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447 02003 8) and 2-count (UPC 8 53447 00204 1) blister cards, Distributed by Consumer Concepts. All product sold between 01/01/13 through 03/27/13. Class I Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomosildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug. Consumer Concepts, Inc.
Drugs BUCALSEP (R) ORAL SOLUTION, (Benzocaine, 600 mg, Cetylpyridinum Chloride 30 mg, Menthol 45 mg Zinc Chloride 30 mg), 1 Fl. Oz. (30 mL), Manufactured for GIL PHARMACEUTICAL CORP, PONCE, PUERTO RICO 00717-1565 -- NDC 58552-103-01 Lot 611614 (exp. 09/2013) Class III Subpotent; Cetylpyridinum Chloride Hi-Tech Pharmacal Co., Inc.
Food Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains Bacillus Coagulans GBI-30-6086 in a base of Maltdextrin. Gluten Free, GMO Free Manufactured for: Juice Bar Solutions, 38 Maybeck St., Novato, Ca 94949. Product of USA Lot # 120615, Best by 8/2014; UPC 6 88683 10800 0 Class III It was discovered that label for Add a Scoop Probiotic stated that it was GMO free, however manufacturers paperwork did not support the claim. Juice Bar Solutions
Devices AMS 800® Urinary Control System. The AMS 800® Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800® Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004  ...
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Class II American Medical Systems, Inc. is initiating a recall on two components of the AMS 800® Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. American Medical Systems, Inc.
Devices AMS 800® Urinary Control System. The AMS 800® Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800® Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck. Model # Lot # 72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002 Class II American Medical Systems, Inc. is initiating a recall on two components of the AMS 800® Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria. American Medical Systems, Inc.
Drugs Acetylcysteine Injection, all strengths and all presentations including 100 mg/mL in 30 mL vials and 200 mg/mL in 30 mL and 50 mL vials, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130129-J, 20130129-L, Exp 04/29/13; 20130405-H, Exp 07/05/13. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Alpha Lipoic Acid Injection, all strengths and all presentations including 25 mg/mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130319-C, Exp 06/19/13; 20130329-C, Exp 06/29/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Amikacin Injection, all strengths and all presentations including 50, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130116-A, Exp 04/16/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Ascorbic Acid Injection, all strengths and all presentations including a) 500 mg/mL, b) corn source 500 mg/mL, c) tapioca 500 mg/mL, d) cassave 500; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130313-M, Exp 6/13/2013; 20130306-N, Exp 6/6/2013; 20130220-E, Exp 5/20/2013; 20130222-D, Exp 5/22/2013; 20130205-B, Exp 5/5/2013; 20130205-C, Exp 5/5/2013; 20130222-F, Exp 5/22/2013; 20130315-H, Exp 6/15/2013; 20130313-L, Exp 6/16/2013; 20130306-O, Exp 6/6/2013; 20130328-A, Exp  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Acetate and Betamethasone Sodium Injection, all strengths and all presentations including 6 mg/mL preservative free, 2 ml; 106 mg/mL 10 mL, and 6 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130114-A, Exp 4/14/2013; 20130123-B, Exp 4/23/2013; 20130124-A, Exp 4/24/2013; 20130212-A, Exp 5/12/2013; 20130321-B, Exp 6/21/2013; 20130319-M, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bacteriostatic Water for Injection, all presentations including 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-C, Exp 4/22/2013; 20130122-D, Exp 4/22/2013; 20130319-A, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs B-Complex Injection, all strengths and all presentations including a) B-Complex Injection 30 mL; b) B-Complex PF 2 mL; c) B-Complex Plus-100; d) B-Complex_B12_30 mL; e) B-Complex-50-Methyl-30-Lido 30 mL; f) B-CompSuper-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) B-Complex: 20130228-B, Exp 5/28/2013; 20130125-B, Exp 4/25/2013; b) B-Complex PF 2ml: 20130219-D, Exp 5/19/2013; 20130319 -J, Exp 6/19/2013; c) B-Complex Plus-100: 20130307-D, Exp 6/7/2013; 20130123-E, Exp 4/23/2013; d) B-Complex_B12_30ml: 20130212-F, Exp 5/12/2013; e) B-Complex-50-Methyl-30-Lido 30ml: 20130206-M, Exp 5/6/2013; f) B-CompSuper-30ml: 1302042000AE, Exp 5/4/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Combination Injection, all strengths and all presentations including a) Beta combo 6 mg/mL, 3 mL, b) Betameth_Combo_PF-6-2 Syr, and c) Betamethasone Combo 6 mg/mL Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Beta combo: 20130123-B, Exp 4/23/201, b) Betameth_Combo_PF-6-2 Syr: 13031230GV1, Exp 6/12/2013; 13032060GV2, Exp 6/20/2013; 13011650GV7, Exp 4/16/2013; 13012330GV1, Exp 4/23/2013; 13020525Gv1, Exp 5/5/2013; c) Betamethasone Combo 6mg/ml Syr: 20130304-GV2, Exp 5/4/2013; 13031230GV1, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs BET-ACE-LIDO-6-2 Injection, all strengths and all presentations including 7 mL syringe and Betameth Combo 6 mg/mL Lidocaine 2% Syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13012320-GV1, Exp 4/23/2013; 13021840GV1, Exp 5/18/2013; 13031150GV1, Exp 6/11/2013; 13021840GV1, Exp 5/18/2013; 13012320-GV1, Exp 4/23/2013; 13011532, Exp 4/15/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Sodium Phosphate Injection, all strengths and all presentations including 6 mg/2 mL PF and 6 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130405-F, Exp 7/5/2013; 20130222-A, Exp 5/22/2013; 20130405-F, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Betamethasone Combination with Lidocaine 1% and Bupivacaine 0.5 % Injection, all strengths and all presentations including a) Betameth combo 6 mg/mL lido 1% bup 0.5% syr; and b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Betameth combo 6mg/ml lido1% bup 0.5% syr: 13021975, Exp 5/19/2013; b) Betameth Combo/Lidocaine 1%/ Bupivacaine 0.5% Syr: 13012550, Exp 4/25/2013; 130215100, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Biotin Injection, all strengths and all presentations including Biotin-15-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130117500AE, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bupivacaine and Dexamethasone Injection, all strengths and all presentations including Bupiv_Dexameth-0.25-10.5; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13011450GV4, 13011450GV1, Exp 4/14/2013; 13011760B, Exp 4/17/2013; 13012450, Exp 4/24/2013; 13021960GV2, Exp 5/19/2013; 2013021950GV2, Exp 5/19/2013; 20130222GV3, Exp 5/22/2013; 13020450GV3, Exp 5/4/2013; 13020850GV2, Exp 5/8/2013; 13031330GV2, Exp 6/13/2013; 13032730GV1, Exp 6/27/2013; 20130327GV2, Exp 6/27/2013; 1303031475GV2, Exp 6/3/2013; 130301100GV2, Exp 6/1/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Bupivacaine Injection, all strengths and all presentations including a) Bupivacaine Parabens Free 0.5% 50 mL, and b) Bupivacaine PF 0.5% 30 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Bupivacaine PF 0.5% 30 mL SDV: 20130318-C, Exp 6/18/2013; 20130319-F, Exp 6/19/2013; b) Bupivacaine Paraben Free 0.5% 50 mL: 20130212-E, Exp 5/12/2013; 20130124-F, Exp 4/24/2013; 20130214-G, Exp 5/14/2013; 20130320-E, Exp 6/20/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Buprenorphine Injection, all strengths and all presentations including Buprenorphine-0.3 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130129300AEB, Exp 4/29/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Vitamin D3 Injection, all strengths and all presentations including a) Cholecalciferol D3 50,000iu 30 mL, b) Calcitriol D3 10,000iu, and c) Calcitriol D3 50,000iu, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-A, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Cyanocobalamin 1000mcg: 20130214-C, Exp 5/14/2013; 20130220-B, Exp 5/20/2013; 20130226-D, Exp 5/26/2013; 20130226-E, Exp 5/26/2013; 20130226-L, Exp 5/26/2013; 20130125-E, Exp 4/25/2013; 20130125-D, Exp 4/25/2013; 20130125-C, Exp 4/25/2013; 20130125-F, Exp 4/25/2013; 20130211-M, Exp 5/11/2013; 20130214-B, Exp 5/14/2013; 20130221-D, Exp 5/21/2013; 20130225-K, Exp 5/25/2013; 20130214-B, Exp 5/14/2013; 20130226-C, Exp 5/26/2013;  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Cyclosporine Injection, all strengths and all presentations including Cyclosporine 2% Aqueous Solution 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-F, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dexamethasone Sodium Phosphate Injection, all strengths and all presentations including a) Dexamethasone Sodium Phosphate 10 mg/1 mL, b) Dexamethasone Sodium Phosphate 10 mg/mL PF 1 mL, c) Dexamethasone Sodium Phosphate 4 mg/30 mL, d) Dexamethasone-4 mg/5 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Dexamethasone Sodium Phosphate 10mg/1ml: 20130402-F, Exp 7/2/2013; b) Dexamethasone Sodium Phosphate 10mg/ml PF 1ml: 20130307-H, Exp 6/7/2013; c) Dexamethasone Sodium Phosphate 4mg/30ml: 20130117-B, Exp 4/17/2013; 20130326-C, Exp 6/26/2013; 20130307-E, Exp 6/7/2013; 20130221-D, Exp 5/21/2013; d) Dexamethasone-4mg/5ml P.F.: 20130328-L, Exp 6/28/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dexpanthenol Injection, all strengths and all presentations including Dexpanthenol 250 mg/30 mL; Dexpanthenol 250 mg/mL 10 mL, 30 mL, 50 mL; and Dexpanthenol 250 mg/mL 10 mL P.F.; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130212-A, Exp 5/12/2013; 20130122-E, Exp 4/22/2013; 20130212-D, Exp 5/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dimercapto-propane-sulfonic acid (DMPS) Injection, all strengths and all presentations including a) DMPS 50 mg/5 mL, b) DMPS 50 mg/mL PF 5 mL, c) DMPS Acid 250 mg/5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) DMPS 50 mg/5 mL: 20130326-F, Exp 6/26/2013; b) DMPS 50 mg/mL PF 5 mL: 20130311-A, Exp 6/11/2013; c) DMPS Acid 250 mg/5 mL: 20130130-K, Exp 4/30/2013; 20130212-C, Exp 5/12/2013; 20130311-A, Exp 6/11/2013; 20130308-M, Exp 6/8/2013; 20130130-E, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Dimethyl Sulfoxide (DMSO) Injection, all strengths and all presentations including DMSO 99% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-L, Exp 4/30/2013; 20130306-G, Exp 6/6/2013; 20130131-L, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Edetate Disodium Injection, all strengths and all presentations including a) Edetate Disodium 150/30 mL and b) Edetate Disodium 150/100 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Edetate Disodium_150/30 mL: 20130201-E, Exp 5/2/2013; b) Edetate Disodium_150/100 mL: 20130124-B, 4/24/2013; 20130213-B, Exp 5/13/2013; 20130213-C, Exp 5/13/2013; 20130401-B, Exp 7/1/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Edetate Calcium Disodium Injection, all strengths and all presentations including a) Edetate Calcium Disodium 300 mg/mL 100 mL, b) Edetate Calcium Disodium 300-30 mL, c) Calcium Edetate 200 mg/mL 15 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Edatate Calcium Disodium 300 mg/mL 100mL: 20130319-H, Exp 6/19/2013; 2010318-N, Exp 6/18/2013; b) Edetate Calcium Disodium 300-30 mL: 20130205-H, Exp 5/5/2013; 20130318-N, Exp 6/18/2013; 20130319-H, Exp 6/19/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs ED Mix Injections, all strengths and all presentations including a) ED mix TM -at 2, b) ED-Mix BI-Mix 10 30 mL, c) ED-Mix BI-Mix 9 30 mL; d) ED-Mix BI-Mix-3-30, e) ED-Mix PGE 80-30, f) ED-Mix SB4 30 mL, g) Ed-Mix ST 9E, h) ED-Mix ST-1, i) ED-MIX T106, j) ED-MIX-PGE-150 30 mL, k) ED-MIX-PGE-40-30, l) ED-MIX-ST 9A, m) ED-MIX-ST 9D, n) ED-MIX-ST-9B, o) ED-MIX-T 101, p) ED-MIX-T105, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) ED mix TM -at 2: 20130306-M, Exp 6/6/2013; b) ED-Mix BI-Mix 10 30 mL: 130207120AE, Exp 5/7/2013; c) ED-Mix BI-Mix 9 30 mL: 20130121-G, Exp 4/21/2013; 20130301-F, Exp 5/1/2013; d) ED-Mix BI-Mix-3-30: 20130124-H, Exp 4/24/2013; 20130305-J, Exp 6/5/2013; e) ED-Mix PGE 80-30: 1302041000AE, Exp 5/4/2013; 20130313-B, Exp  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Estradiol Cypionate Injection, all strengths and all presentations including a) Estradiol Cypionate 5 mg/mL 10 mL and b) Estradiol Cypionate 10 mg/mL 10 ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130226-F, Exp 5/26/2013; 20130117-K, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Estradiol Valerate Injection, all strengths and all presentations including a) Estradiol Valerate 40-10 mL and b) Estradiol Valerate 40-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130114-B, Exp 4/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Folic Acid 10 mg/30 mL: 20130204-D, Exp 5/4/2013; b) Folic Acid PF 10mg/mL 2 mL: 20130219-E, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Furosemide Injection, all strengths and all presentations including a) Furosemide PF-10 mg-10 mL, b) Furosemide PF-10 mg-2 mL SDV, and Furosemide 10 mg/mL 4 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Furosemide PF-10 mg-10 mL: 20130201-F, Exp 5/1/2013; b) Furosemide PF-10 mg-2 mL SDV: 20130306-F, Exp 6/6/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Gentamicin Injection, all strengths and all presentations including a) Gentamicin 40 mg/2 mL, b) Gentamicin 40 mg/30 mL, c) Gentamicin-40-20 mL, d) Gentamicin-40 mg/mL-2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Gentamicin 40 mg/2 mL: 20130403-D, Exp 7/3/2013; 20130227-H, Exp 5/27/2013; b) Gentamicin 40 mg/30 mL: 20130204-E, Exp 5/4/2013; c) Gentamicin-40-20 mL: 20130204-E, Exp 5/4/2013; d) Gentamicin-40 mg/mL-2 mL; 20130227-A, Exp 5/27/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Glycerin/Lidocaine/Epinephrine Injection including Glycerin 72% Lido:Epi 2-1-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130211-U, Exp 5/11/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Human Chorionic Gonadotropin Injection, all strengths and all presentations including a) HCG 1000u/mL, b) HCG 1000u/mL 10mL, c) HCG 1000u Folic 400 mcg Methyl 5 mg 10 mL, d) HCG Kit 1 Day w/ Drug; HCT 750u/0.75 mL Pre-Filled Syringe, e) HCG Syringe 150iu/0.15 mL, f) HCG 1500u/1.5 mL Pre-Filled Syringe, g) HCG 5000 unit/5 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) HCG 1000u/mL: 20130319-E, Exp 5/19/2013; b) HCG 1000u/mL 10mL: 20130221-J, Exp 4/21/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hyaluronidase Injection, all strengths and all presentations including a) Hyaluronidase 150u/mL, b) Hyaluronidase 150u/ml 1 mL PF, c) Hyaluronidase 150u/mL PF 1ml SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hyaluronidaise 150u/mL: 20130205-G, Exp 5/5/2013; b) Hyaluronidase 150u/mL 1 mL PF: 20130321-A, Exp 6/21/2013; c) Hyaluronidase 150u/mL PF 1ml SDV: 20130313-E, Exp 6/13/2013. . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hydrochloric Acid 0.6%: 20130212-H, Exp 5/12/2013; b) Hydrochloric Acid 2%: 2013012952000AE, Exp 4/29/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydrogen Peroxide Injection, all strengths and all presentations including Hydrogen Peroxide 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130225-H, Exp 5/25/2013; 20130130-I, Exp 4/30/2013; 20130311-I, Exp 6/11/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Hydroxocobalamin 1000 mcg/mL 30 mL: 20130321-C, Exp 6/21/2013; 20130404-H, Exp 7/3/2013; 20130225-H, Exp 5/25/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Hydroxyprogesterone Caproate Injection, all strengths and all presentations including Hydroxyprogesterone Caproate 250 mg/mL 1 mL, 4 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Hydroxyprogesterone Caproate 250 mg/mL 4 mL: 20130204-A, Exp 5/4/2013; 20130117-G, Exp 4/17/2013; 20130204-A, Exp 5/4/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Ketorolac Injection, all strengths and all presentations including a) Ketorolac 30 mg/mL 10 mL MDV, b) Ketorolac 30 mg/mL 2 mL SDV, c) Ketorolac 30 mg/mL 1 mL SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Ketorolac 30 mg/mL 10 mL: 20130327-B, Exp 6/27/2013; b) Ketorolac 30 mg/mL 2 mL: 20130326-B, Exp 6/26/2013; 20130307-C, Exp 6/7/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Carnitine Injection, all strengths and all presentations including L-Carnitine 500 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130402-G, Exp 7/2/2013; 20130129-H, Exp 4/29/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Glutathione Injection, all strengths and all presentations including a) L-Glut-100 mg-30 mL, b) L-Glut-200 mg/30 mL, c) Glutathione 200 mg/ML P.F. 10 mL, d) L-Glutathione-200-30 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) L-Glut-100 mg-30 mL: 20130213-D, Exp 5/13/2013; b) L-Glut-200 mg/30 mL: 20130318-J, Exp 6/18/2013; 20130301-C, Exp 6/1/2013 ; d) L-Glutathione-200-30 mL, 30 mL: 20130205-A 5/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lidocaine Injection, all strengths and all presentations including a) Lidocaine _HCl-0.5%, b) Lidocaine HCl, c) Lidocaine 1%, d) Lidocaine 1% 50 mL, e) Lidocaine 2 %, f) Lidocaine 2% 50 mL, g) Lidocaine 2% 50 mL MDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lidocaine _HCl-0.5%: 20130403-J, 20130403-F, 20130403-H, 20130403-G, 20130403-I, Exp 7/3/2013; 2013117-I, Exp 4/17/2013; b) Lidocaine HCl: 20130131-H, Exp 4/30/2013; c) Lidocaine 1%: 20130204-N, Exp 5/4/2013; 20130115-A, Exp 4/15/2013; 20130128-E, Exp 4/28/2013; 20130220-G, Exp 5/20/2013; 20130221-J, Exp 5/21/2013; 20130221-K, Exp 5/21/2013; 20130204-J, Exp 5/4/2013; 20130315-J, Exp  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lipo W/ Vitamin 100 mL: 20130322-D, Exp 6/22/2013; 20130115-H, Exp 4/15/2013; b) Lipo W/ Vitamins 30 mL: 20130228-H, Exp 5/28/2013; 20130228-H, Exp 5/28/2013; 20130322-D, Exp 6/22/2013; 20130208-J, Exp 5/8/2013; c) Lipo W/Vitamin: 20130228-H, Exp 5/28/2013; d) Lipo w/Vitamins #5 30 mL: 201301281000IN, Exp 4/28/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Lipo w/Vitamins-methylcobalamin 100 mL: 20130225-A, Exp 5/25/2013; 20130326-D, Exp 6/26/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs L-Lysine Injection, all strengths and all presentations including a) L-Lysine_100-30 mL, b) L-Lysine_100 mg/30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) L-Lysine_100-30 mL: 130117300AE, Exp 4/17/2013; 20130118-F, Exp 4/18/2013; 20130129-G, Exp 4/29/2013; 20130131-G, Exp 4/30/2013; b) L-Lysine_100 mg/30 mL: 20130405-E, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Magnesium Chloride Injection, all strengths and all presentations including a) Magnesium Chloride 200 mg/50 mL and b) Magnesium Chloride 200 mg/mL 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Magnesium Chloride 200 mg/50 mL: 20130321-F, Exp 6/21/2013; 20130319-I, Exp 6/19/2013; b) Magnesium Chloride 200 mg/mL 50mL: 20130307-F, Exp 6/7/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Magnesium Sulfate 50%: 20130130-F, Exp 4/30/2013; 20130128-F, Exp 4/28/2013; 20130221-T, Exp 5/21/2013; b) MAGNESIUM SULFATE 50% 50 mL: 20130322-E, Exp 6/22/2013; 20130219-C, Exp 5/19/2013; 20130307-A, Exp 6/7/2013; 20130404-G, Exp 7/4/2013; c) Magnesium Sulfate PF 50% 2 mL: 20130227-F, Exp 5/27/2013; 20130312-G, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Manganese-0.1 30 mL: 20130129500JN, Exp 4/29/2013; 1301302000AE, Exp 4/30/2013; b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G, Exp 7/5/2013; c) Manganese Sulfate 5 mg/5 mL: 20130122-4, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Medroxyprogesterone Acetate Injection, all strengths and all presentations including a) Medroxyprogesterone 150-30 mL, b) Medroxyprogesterone Acetate 150 mg/mL in 1 mL, 10 mL, 30 mL vials, c) Medroxyprogesterone Acetate 150 mg/mL PF syringe, d) Medroxyprogesterone Acetate 150 mg/mL syringe, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Medroxyprogesterone 150-30 mL: 20130301-H, Exp 6/1/2013. Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylcobalamin Injection, all strengths and all presentations including a) Methylcobalamin 1000 mcg/mL in 10 mL, 30 mL, 50 mL, 60 mL, b) Methylcobalamin 1000 mcg 30 mL, c) Methylcobalamin 5 mg/mL 30 mL, d) Methylcobalamin PF 1000 mcg/mL in 2 mL, 5 mL, 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylcobalamin 1000 mcg: 20130208-G, Exp 5/8/2013; 20130118-G, Exp 4/18/2013; 20130129-E, Exp 4/29/2013; 20130212-B, Exp 5/12/2013; 20130221-I , Exp 5/21/2013; 20130206-D, Exp 5/6/2013; 20130301-E, Exp 6/1/2013; 20130305-C, Exp 6/5/2013; b) Methylcobalamin  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone Acetate and Marcaine Injection, all strengths and all presentations including a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75, b) Methylpred_Marc-0.25-0.27, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot#: a) Methylpred 80 mg/mL and Marcaine 0.25%-2.75: 130312200GV3, Exp 6/12/13; b) Methylpred_Marc-0.25-0.27: 13011536, Exp 4/15/2013; 20130226-GV2, Exp 5/26/2013; 13012335GV4, Exp 4/23/2013; 13012460GV2, Exp 4/24/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone and Dexamethasone Injection, all strengths and all presentations including a) Methylpred/ Dexameth 1-2-3 mL and b) Methylpred/Dexa 3 mL PFS; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylpred/ Dexameth 1-2-3 mL: 13040150GV1, Exp 7/1/2013; 13032750GV3, Exp 6/27/2013; b) Methylpred/Dexa 3 mL PFS: 13032050GV4, Exp 6/20/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone and Bupivacaine Injection, all strengths and all presentations including Methylpred80mg/bupivacaine0.25% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 13012335-GV4, Exp 4/23/2013;; 20130226-GV2, Exp 5/26/2013; 130312200GV3, Exp 6/12/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone, Lidocaine, and Sodium Chloride Injection, all strengths and all presentations including a) Methylpred-Lido-Nacl-1-5-6-12 syringe and b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Methylpred-Lido-Nacl-1-5-6-12 syringe: 20120226-GV3, Exp 5/26/2013; 13012370GV3, Exp 4/23/2013; 13012480, Exp 4/24/2013; 13011550, Exp 4/15/2013; b) Methylpred80mg/lido1%/Sodium Chloride0.9% syr: 13012370-GV3, Exp 4/23/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 130305600AE, Exp 6/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Methylprednisolone Acetate Injection, all strengths and all presentations including a) Methylprednisolone Acetate 40 mg/mL, b) Methylprednisolone Acetate (PF) 40 mg/mL, c) Methylprednisolone Acetate (PF) 80 mg/mL, d) Methylpred Acetate 40 mg/mL 1 mL, e) Methylprednisolone 80 mg/5 mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. a) Methylprednisolone Acetate 40 mg/mL: 20130228-E, Exp 5/28/2013; 2013012370-GV3, Exp 4/23/2013; 20130318-D, Exp 6/18/2013; b) Methylprednisolone Acetate (PF) 40 mg/  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Metoprolol Injection, all strengths and all presentations including Metoprolol 1 mg/mL 5 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-B, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL, i) MIC-25-50-25 Cyano 1000 mcg/mL 30 mL, j) MIC-25-50-50-30 mL, k) MIC-8-15-15-30, l) MIC-B12-30, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) MIC 25-50-25-30 mL: 20130130-D, Exp 4/30/2013; 20130214-F, Exp 5/14/2013; b) MIC_B_COMP-B12-25-50-50-1000-30 mL: 1303261000AE, Exp 6/26/2013; c) MIC_B12-25-50-25-400-30 mL: 20130307-I, Exp 6/7/2013; 20120206-H, Exp 5/6/2013; d) MIC_B6_B12-30 mL: 20130208-E, Exp 5/8/2013; e) MIC_METH_VIT-#3-30 mL: 1302072000AE, Exp 5/7/2013; f) MIC_METH-25-50-50-1000 mcg 30 mL: 20130326-G, Exp 6/26/2013; g) MIC_ULTRA-30 mL:  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130321-E, Exp 6/21/2013; b) 20130215-F, Exp 5/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Nandrolone Decanoate Injection, all strengths and all presentations including a) Nandrolone Decanoate 300 mg/mL, b) Nandrolone 200 mg/mL, c) Nandrolone 250 mg/mL, d) Nandrolone 350 mg/mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Nandrolone Decanoate 300 mg/mL: 20130311-J, Exp 6/11/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Phenylephrine Injection, all strengths and all presentations including Phenylephrine 1% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130129-F, Exp 4/29/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Phosphatidylcholine and Sodium Deoxycholate Injection, all strengths and all presentations including Phospha_Deoxy-35-30-50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 201303071500JN, Exp 6/7/2013; 1301231000AE, Exp 4/23/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Polidocanol Injection, all strengths and all presentations including a) Polidocanol 5% 30 mL, b) Polidocanol 1% 30 mL, c) Polidocanol 2% 30 mL, d) Polidocanol 3% 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Polidocanol 5% 30 mL: 20130319-I, Exp 6/19/2013; 20130326-H, Exp 6/26/2013; b) Polidocanol 1% 30 mL: 20130118-B, Exp 4/18/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Procaine Hydrochloride Injection, all strengths and all presentations, including a) Procaine 2% 30 mL PF, b) Procaine HCl 2% 10 mL, c) Procaine HCl 20 mg/mL 30 mL, d) Procaine HCl 1% 50 mL MDV, e) Procaine HCl 1% PF 5 mL, 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) 20130405-B, Exp 7/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Progesterone Injection, all strengths and all presentations including a) Progesterone 100 mg/mL 10 mL, 30 mL b) Progesterone 50 mg/mL 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Progesterone 100 mg/mL 10 mL: 20130306-E, Exp 6/6/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Pyridoxine Hydrochloride Injection, all strengths and all presentations including Pyridoxine 100 mg/mL 30 mL, 50 mL, and 10 mL PF SDV, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130130-J, Exp 4/30/2013; 20130225-D, Exp 5/25/2013; 20130315-I, Exp 6/15/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Chloride and Dexamethasone Injection, all strengths and all presentations including a) SOD_CHLOR-DEXAMETH-0.9-10-3, b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) SOD_CHLOR-DEXAMETH-0.9-10-3: 13011450GV3, Exp 4/14/2013; 13011450GV2, Exp 4/14/2013; 13011760A, Exp 4/17/2013; 13012440, Exp 4/24/2013; 13020425GV2, Exp 5/4/2013; 2013021950GV1, Exp 5/19/2013; b) SOD_CHLORIDE/DEXAMETH syringe 0.9-10-3: 13031330GV1, Exp 6/13/2013; 13031460GV1, Exp 6/14/2013; 13032740GV2, Exp 6/27/2013; 20130327GV1, Exp 6/27/2013; 13021920GV1, Exp 5/19/2013; 130301100GV3, Exp 6/1/2013; 20130222GV2, Exp 5/22/2013; 13020850GV1, Exp 5/8/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Bicarbonate and Lidocaine Injection, all strengths and all presentations including Sod-Bicarb-Lido-0.27-2.73-3 syr, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130226-GV4, Exp 5/26/2013; 13031150GV3, Exp 6/11/2013; 13031240GV4, Exp 6/12/2013; 13012325GV5, Exp 4/23/2013; 13021820GV3, Exp 5/18/2013; 13011520, Exp 4/15/2013; 13012425GV1, Exp 4/24/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Nandrolone Decanoate and Testosterone Cypionate Injection, all strengths and all presentations including a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL and b) Nandrolone 100 mg/mL TestCyp 200 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Nandrolone 100 mg/mL TestCyp 100 mg/mL 10 mL: 130220060AE, Exp 5/20/13 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Bicarbonate Injection, all strengths and all presentations including: a) Sodium Bicarb 4.2% 5 mL PF, b) Sodium Bicarb 8.4% 50 mL SDV, c) Sodium Bicarbonate 8.4%, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Sodium Bicarb 4.2% 5 mL PF: 130123150AE, Exp 4/23/2013; b) Sodium Bicarb 8.4% 50 mL SDV: 20130315-L,  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Chloride Injection, all strengths and all presentations including a) Bacteriostatic Sodium Chloride 0.9% 30 mL, b) Sodium Chloride 23.4% 30 mL PF, and c) Sodium Chloride 23.4% 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Bacteriostatic Sodium Chloride 0.9% 30 mL, 20121205, Exp 6/11/2013; b) Sodium Chloride 23.4% 30 mL PF: 20130115-G, Exp 4/15/2013; c) Sodium Chloride 23.4% 50 mL: 20130114-E, Exp 4/14/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Sodium Tetradecyl Sulfate Injection, all strengths and all presentations including a) Sodium Tetradecyl Sulfate 3% 50 mL, b) Sodium Tetradecyl Sulfate 3% mL, c) Sodium Tetradecyl Sulfate-2% 30 mL, d) Sodium Tetradecyl Sulfate-2.5% 20 mL, e) Sodium Tetradecyl Sulfate 0.3% 30 mL, f) Sodium Tetradecyl Sulfate 1% 30 mL, 50 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Sodium Tetradecyl 3% 50 mL: 20130318-G, Exp 6/18/2013; b) Sodium Tetradecyl 3% mL: 20130218-G, Exp 5/18/2013; c) Sodium Tetradecyl-2% 30 mL: 20130122-B, Exp 4/22/2013; d) Sodium Tetradecyl-2.5% 20 mL: 20130114-D, Exp 4/14/2013; 20130117-C, Exp 4/17/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Cypionate and Testosterone Propionate Injection, all strengths and all presentations including a) Testosterone cyp 200/test prop 20 mg 10 mL and b) Testosterone Cyp 200 mg/Test Prop 50 mg 10mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Testosterone cyp 200/test prop 20 mg 10 mL: 130102500AE, Exp 4/25/2013; b) Testosterone Cyp 200 mg/Test Prop 50 mg 10 mL: 20130305-1, Exp 6/5/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Taurine Injection, all strengths and all presentations including a) Taurine 50 mg/mL, b) Taurine-50-30 mL, c) Taurine-50 mg-30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: Taurine 50 mg/mL: 20130305-A, Exp 6/5/2013; Taurine-50-30 mL: 20130123-D, Exp 4/23/2013; Taurine-50mg-30 mL: 21030117-J, Exp 4/17/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Propionate, Testosterone Cypionate, and Nandrolone Decanoate Injection, all strengths and all presentations including Test Prop 100 mg/Test Cyp 50 mg/nandro dec 150 mg/ml, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: 20130122-G, Exp 4/22/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Testosterone Cypionate Injection, all strengths and all presentations including a) Testosterone Cyp 200 mg/10 mL; b) Testosterone Cypionate 100 mg/10mL; c) Testosterone Cypionate 200 mg 10 mL; d) Testosterone Cypionate 200 mg 30 mL; e) Testosterone Cypionate 200 mg/mL; f) Testosterone Cypionate 200 mg/mL 30 mL; g) Testosterone Cypionate Sesame 200 mg/10 mL; h) Testosterone Cyp 250/30 mL; i) Testosterone Cypionate 200 mg/mL; Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Testosterone Cyp 200 mg/10 mL: 20130128-A, Exp 4/28/2013; b) Testosterone Cypionate 100 mg/10 mL: 20130226-G, Exp 5/26/2013; 130402100AE, Exp 7/2/2013; c) Testosterone Cypionate 200 mg 10 mL: 20130220-A, Exp 5/20/2013; 20130306-L, Exp 6/6/2013; 20130221-C, Exp 5/21/2013; 20130320-A, Exp 6/20/2013; 20130403-B, Exp 7/3/2013; 20130208-A, Exp 5/8/2013; 20130215-C, Exp  ...
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Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Thiamine 100 mg/30 mL: 20130130-G, Exp 4/30/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Triamcinolone Injection, all strengths and all presentations including a) Triamcinolone 40 mg/1 mL PF, b) Triamcinolone Acetonide 45 mg/mL, c) Triamcinolone 50 mg/mL 5 mL PF, d) Triamcinolone 45 mg/mL10 mL, 30 mL, e) Triamcinolone 40 mg/mL SDV PF 1 mL, 2 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Triamcinolone 40 mg/1 mL PF: 20130314-K, Exp 6/14/2013;b) Triamcinolone Acetonide 45 mg/mL: 20130129-I, Exp 4/29/2013; 20130208-B, Exp 5/8/2013; 20130314-K, Exp 6/14/2013; 20130318-E, Exp 6/18/2013; 20130308-1, Exp 6/8/2013 Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Drugs Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014. Lot #: a) Zinc Sulfate 10 mg/30 mL: 20130404-A, Exp 7/4/2013; b) Zinc Sulfate 1 mg/10 mL: 20130206-B, Exp 5/6/2013 . Class II Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. FVS Holdings, Inc. dba. Green Valley Drugs
Devices BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood. Used for culturing microorganisms. Model number 221239: lot 2348199 with expiration date 4/5/13; and model number 221261: lot 2348208 with expiration date 3/22/13, lot 2355145 with expiration date 4/2/13, lot 2339019 with expiration date 4/5/13, lot 2348157 with expiration date 4/6/13, lot 2361011 with expiration date 4/6/13, lot 2348202 ,with expiration date 4/6/13, lot  ...
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Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate. Used for culturing microorganisms. Model number 221291: lot 2355138 with expiration date 3/6/13, lot 2355164 with expiration date 3/8/13 Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices BBL(tm) CDC Anaerobe 5% Sheep Blood Agar. Used for culturing microorganisms. Model number 221733: lot 2361003 with expiration date 3/14/13 Class II Microbiological media may be contaminated with bacteria. Becton Dickinson & Co.
Devices Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The large distance of more than 16mm between cannula ends and posterior pole guarantees sufficient light in the working area and a large observation field especially when used in conjunction with modern wide field panoramic observation systems. Lot Numbers: M53157, M55115, M56929, M58551, M61862. Class II Insight Instruments, Inc., Stuart, FL is recalling M.I.S. (Multi-Port Illumination System), Ophthalmic Cannula due to a misclassification of the medical device. Insight Instruments, Inc.
Devices Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. Product 80530: 032887164, 203184264,110983764, 208286764, 116480564, 221590564, 120987864, 236385564,127085464; Product 8508: 207383964, 23489464 Class III On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. Covidien LLC
Devices Curity Staple Remover Kit; Product Code: 66701. Staple Remover Kit. 103387264, 117881264, 110983964, 214981164, 117488864 Class III On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. CareFusion is recalling a variety of OTC drug products including the 10% Povidone Iodine SEPP Applicator which is utilized in specific convenience kits. Covidien LLC
Food Island Mix, 12 oz. with best by date of 02/17/2014 Best by Date of 02/17/2014 Class II Incorrect labeling and undeclared allergens , including Peanuts, Cashews, Almonds, Consumers who have an allergy or sensitivity to peanuts, Cashews, Almonds run the risk of serious or life-threatening allergic reactions. The product Island Mix packaged in a clear bag (dried fruit mixture) contained Peanuts, Cashews, Almonds. Nuts Are Good! Inc.
Devices Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series. Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013 Class II The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples. Iris Diagnostics
Food Dried Mango (3.5oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Dried Mango contains undeclared sulfites/preservatives. S & M International Inc
Food Grove Grow Notes Hawthorne , 400 Gram (14 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Deputy: S&M (USA) Enterprise 4703 2nd Avenue, Brooklyn, NY 11232. Product of China. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Grove Grow Notes Hawthorne contains unallowed dye 16255,Ponceau 4R (E124)- Acid Red 18 and FD& C Yellow #5 S & M International Inc
Food Tasty Snacks Sour Plum, (6 oz.), S&M(HK) Enterprise LTD, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Product of China. Item No. 802578. All lots Class II The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Tasty Snacks Sour Plum contains undeclared sulfites/preservatives, contains unallowed dye:16185-Amaranth (E123)-Acid Red 27 and contains undeclared FD & C Yellow #6 S & M International Inc
Food Lam Sheng Kee Chinese Red Dates, (Net Weight 400 Grams), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. Item #803810; Product of China. All lots Class III The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Red Dates contain unallowed dye basic violet 3. S & M International Inc
Food Lam Sheng Kee Mini Sausage Hong Kong Style, Net Weight 6.3 oz.), Lam Sheng Kee (HK) International Limited, RM3 8/F Yuexiu BLDG., 160-174, Lockhart Road, Wan Chai, HK. Distributed By: S&M Int'l Inc. 100 Pulaski Street, Bayonne, NJ 07002. All lots Class III The recall was initiated after it was discovered through NYDAM Sampling which revealed the product Lam Sheng Kee Mini Sausage contains undeclared FD&C Red #40 and undeclared minced fish (unknown fish species) S & M International Inc
Devices Liquichek" ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays. Analytes claimed with this lot of Liquichek ToRCH Plus IgM Control: · Cytomegalovirus (CMV) IgM · Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM · Rubella Virus IgM · Toxoplasma gondii IgM Lot Number 18972, Catalog Number 229 and 229PX. Class III The Liquichek" ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the mouse monoclonal antibody conjugation process for this product. Bio-rad Laboratories, Inc.
Drugs Walmart Amlodipine Besylate Tablets, USP 10 mg, Rx only, 30 tablets, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY. Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ. Distributed by: Wal-Mart Stores, Inc., Bentonville, AR. Packaged by: Legacy Pharmaceutical Packaging, LLC, Earth City, MO. NDC 68645-445-70. Lot # 130251, 130252, 130253 Exp date: 11/14 Class II Labeling: Labeling Error on Declared Strength; product label incorrectly states Amlodipine 5 mg instead of Amlodipine 10 mg. Tablet strength is 10 mg Legacy Pharmaceutical Packaging LLC
Devices Zilver® PTX® Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps Preven the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to:  Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD .  improve blood flow to the extremity. REF ZIV6-35-125-6-80-PTX ; REFG24890 UDI 10827002248905 All lots distributed prior to 4/16/2013 Class I Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported. Cook, Inc.
Devices Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity. REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13 Class I Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation was reported. Cook, Inc.
Devices Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose rate brachytherapy to treat vaginal and rectal cancer. Serial numbers H640383, H640277, H640384, H640788, H640D126, H640385, H640372, H640303, H640387 Class II Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. Varian Medical Systems, Inc.
Drugs Glenmark Gabapentin Tablets, a) 600mg, 500- count bottle (NDC 68462-126-05), b) 800 mg, 500- count bottle (NDC 68462-127-05), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India, Manufactured for : Glenmark Generics USA Mahwah, NJ 07430. a) 600mg: Lot# 02123419, Exp 10/14 Lot# 02123424, Exp  ...
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Class III Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Drugs Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for :Glenmark Generics USA Mahwah, NJ 07430 Lot # 02121059 Exp 03/15 Lot # 02121484 Exp 04/15 Lot # 02121530 Exp 04/15 Lot# 02121665 Exp 05/15 Lot# 02121669 Exp 05/15 Lot# 02121689 Exp 05/15 Lot# 02121705 Exp 05/15 Lot# 02123434 Exp 10/15 Lot# 02123446 Exp 10/15 Lot# 02123633 Exp 11/15 Lot# 02123677 Exp 11/15 Lot# 02123685 Exp 11/15 Lot# 02123695 Exp 11/15 Lot# 02123823 Exp 11/15 Lot# 02123833 Exp 11/15 Lot# 02123836 Exp 11/15 Lot# 02123853 Exp 11/15 Lot# 02123859 Exp 11/15 Lot# 02130021 Exp 12/15 Lot# 02130059 Exp 12/15 Lot# 02130079 Exp 12/15 Class III Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Drugs Glenmark Topiramate Tablets, 200 mg, 60-count bottle, (NDC 68462-110-60), Rx only, Manufactured by Glenmark Generics Ltd.Colvale- Bardez Ltd 403513, India Manufactured for : Glenmark Generics USA Mahwah, NJ 07430 Lot# 02123782, Exp 11/14 Class III Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature. Glenmark Generics Inc., USA
Devices Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27,H29, HCX, Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. CODES: H140001 H140064 H140137 H140721 H140796 H140862 H260947 H270267 H270428 H270539 H270708 H270828 H271017 H140002 H140065 H140139 H140723 H140797 H140863 H260949 H270271 H270430 H270540 H270709 H270829 H271018 H140003 H140066 H140141 H140724 H140798 H140865 H260950 H270273 H270431 H270542 H270710 H270833 H271019 H140004 H140067 H140143 H140725 H140799 H140866 H260951 H270277 H270435 H270544  ...
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Class II Varian has identified that under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to approximately 7% before interlock occurs. At maximum asymmetry, this may result in no more than approximately 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control. Varian Medical Systems, Inc. Oncology Systems
Food Early Bird Foods & Co. CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix, Net Wt. 12 oz packaged in clear plastic bag. Each case contains 12 packages. UPC: 6 89466 30000 0. BEST ENJOYED BY: OCT 18 2013 Class II Early Bird Foods & Co. LLC is recalling CHOC-A-DOODLE-DOO featuring DARK CHOCOLATE & COCONUT granola snack mix due to Undeclared Soya lecithin. Early Bird Foods & Co., LLC
Devices GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100, Innova 4100. For use in generating fluoroscopic images of human anatomy for diagnostic and interventional procedures. Serial # 00000520055BU5 00000009C20026 00000007C20159 00000007C20161 00000008C2M001 0000009C2M0068 00000007C20152 00000519147BU3 00000466843BU0 00000489559BU5 00000009C20099 00000009C20109 00000466851BU3 00000008C20053 00000519174BU7 00000008C20312 00000008C20210 00000007C20391 00000007C20039 00000007C20322 00000008C20079 00000478341BU1 00000536797BU4 00000009C20075 00000008C20214 00000009C20017 00000498702BU0 00000498705BU3 00000007C20324 00000008C20221 00000465840BU7 00000007C20198 00000007C20183 00000536791BU7 00000008C20224 00000008C20227 00000478340BU3 0000009C2M0119 0000009C2M0127 00000532669BU9 00000007C20117 00000009C20036 00000520074BU6 00000007C20012 00000008C20084 00000007C20219 00000536790BU9 00000489715BU3  ...
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Class II While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due to a relay failure in the power distribution box (PDB). Although no injuries have been reported due to this issue to date, there is risk of complications during the procedure as a result of imaging functionality loss. GE Healthcare, LLC
Devices Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN 55121 Use to make an incision in the tympanic membrane. Lot No. 121012 Class II Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. The box contains Myringotomy Spear Blade (Juvenile). Summit Medical, Inc.
Food Grippo's Potato Chips, 1oz, 1 1/8oz , 1¾oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61701 5 Product Quantity Distributed: 1,410cs/60/1oz bags; 860cs/48/1 1/8oz bags; 5,802cs/24/1¾oz bags; 2,517cs/18/3.5oz bags; 11,701cs/6/Twin Pks; 2,009cs/9/8oz bags; 234cs/6/12oz bags; 71cs/36/1oz bags & 21,970/1.5# boxes. All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's BAR-B-Q FLAVORED POTATO CHIPS, 1oz, 1 1/8oz, 1¾oz, 3.5oz, 8oz, 12oz bags & 1.5lb boxes, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SUGAR, TORULA YEAST, SPICES, MONOSODIUM GLUTAMATE, CORN FLOUR ONION POWDER, GARLIC POWDER, NATURAL HICKORY SMOKE FLAVOR, CARMEL COLOR, PAPRIKA EXTRACT, SILICON DIOXIDE. CONTAINS: SULFITES. www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 13131 3 Product Quantity Distributed: 19,685cs/60/1oz bags; 19,755cs/48/1 1/8oz bags; 56,217cs/24/1¾oz bags; 61,413cs/18/3.5oz bags; 88,940cs/6/Twin Pks; 59,790cs/9/8oz bags; 42,204cs/6/12oz bags; 73,685cs/36/1oz bags & 152,845/1.5# boxes. All bagged products with an expiration date of May 20th and prior, all 1.5# boxes with an expiration date of April 29 and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's Sweet BERMUDA ONION FLAVORED POTATO CHIPS, 1oz, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, SWEET BERMUDA ONION SEASONING***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 61703 9 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's Salt & Vinegar FLAVORED POTATO CHIPS, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, LACTOSE, SALT, DEXTROSE, SODIUM DIACETATE, MALIC ACID, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED CONTAINS: MILK***www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14125 1 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's CHEDDAR CHEESE WITH A TOUCH OF JALAPENO natural & Artificially Flavored POTATO CHIPS, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, GRANULAR CHEESE (MILK, CHEESE CULTURES, SALT ENZYMES), MONOSODIUM GLUTAMATE, PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OIL, SPICES, SUGAR, DEXTROSE, WHEY PROTEIN CONCENTRATE, LACTOSE MALTODEXTRIN, CITRIC ACID, BLUE CHEESE (MILK, CHEESE CULTURES, SALT, ENZYMES), SODIUM PHOSPHATE, CORN STARCH, YEAST EXTRACT, ONION, GARLIC, MODIFIED CORN STARCH, JALAPENO PEPPER, NATURAL AND ARTIFICIAL FLAVOR (CONTAINS MILK) ARTIFICIAL COLORS***LACTIC ACID AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 76847 14127 5 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food Grippo's HOT DILL PICKLE Artificially Flavored Potato Chips, 1¾oz, 3.5oz, INGREDIENTS: SELECTED POTATOES, VEGETABLE OIL***AND SALT, WHEY, MALTODEXTRIN, MODIFIED CORN STARCH, SUGAR, MONOSODIUM GLUTAMATE, SODIUM DIACETATE, SPICES, ONION, GARLIC VINEGAR SOLIDS, NATURAL AND ARTIFICIAL FLAVOR, AND NOT MORE THAN 2% SILICON DIOXIDE ADDED www.grippopotatochips.com GRIPPO POTATO CHIP CO, INC. CINCINNATI, OH 45239 UPC: 0 7684714126 8 All bagged products with an expiration date of May 20th and prior. Class II During an inspection by the Ohio Department of Agriculture, the firm was notified of numerous metal fragments in the salt hopper. Grippo Potato Chip Co., Inc.
Food La Romanella Precooked Tri Color Cheese Tortellini, 2.5-lb bag Best By Dates: 12/25/2013, 1/15/2014, 3/15/2014, 4/2/2014, 4/13/2014, 4/15/2014, 4/16/2014, 5/20/2014, 6/1/2014, 6/3/2014, 7/9/2014, 7/19/2014, 7/29/2014, 8/8/2014, 8/26/2014, 9/9/2014, 9/16/2014, 9/17/2014, 10/2/2014 Class II No ingredient statement on pacakge. Product contains undeclared allergens: wheat, egg, and milk. SMART AND FINAL STORES CORP
Food CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand FUDGE BROWNIE COOKIES, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Corner Rt 31 + Rt 93, Lockport, NY 14094 - 716-433-2248 (phone) --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: COOKIE: Flour, Sugar, Vegetable Shortening, Evaporated Milk, Eggs, Chocolate Chips, Cocoa, Baking Powder, Vanilla. FROSTING: Sugar, Vegetable Oil, Corn Syrup, Cocoa, Mono + Diglycerides, Polysorbate 60, Potassium Sorbate, Citric Acid, Lecithin, Salt, Flavorings. "Sell by Dates" of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) Class I Carson's Fudge Brownie Cookies contain undeclared walnuts, wheat (flour) and soy (lecithin). Carson's Country Market
Food CARSON'S HOMEMADE PIES AND OTHER GOOD THINGS brand ASSORTED COOKIE PACK Chocolate Chip - Fudge Brownie - Vanilla Drop - Molasses - Oatmeal Raisin - Peanut Butter - Pumpkin, NET WT. 14 OZ., UPC 7 53182 15240 0 --- Sanborn, NY 14132 --- The cookies are packaged in clear, hard plastic containers with seven or eight cookies per container. --- INGREDIENTS: Veg. Shortening, Flour, Sugar, Eggs, Vanilla. May Contain: Chocolate Chips, Cocoa, Peanut Butter, Milk (Evaporated), Molasses, Oatmeal, Baking Powder, Soda, Cinnamon, Nutmeg, Ginger Or Cloves. "Sell by Dates" of 4/26/2013 to 5/03/13 (date code can be found on the white sticker label found on the top of the hard plastic container) Class I Carson's Assorted Cookie Pack contains undeclared walnuts, wheat (flour), milk and peanut (butter). Carson's Country Market
Food Asia Best Salted Mackerel, 7 oz. vacuum packages, 25 pkgs/cases; labeled in part ***Eastland Food Corp. 8305 Stayton Drive Jessup, MD 20794 *** Product of Thailand *** Keep Frozen *** UPC 851035 408024*** Best Before - February 29, 2014 Class II Salted mackerel contains histamines at a level indicating product decomposition. Eastland Food Corporation
Devices DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg Part No. 5200-68-000 The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique. Lot - D12178C Class III LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves. DePuy Orthopaedics, Inc.
Devices PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C. The PadPro(R) Adult Radiotransparent Multifunction Electrodes with Carbon Leadwires and Medtronic(R) Connector are intended to be used in external pacing, defibrillation and monitoring applications Lot Code Y092012-21, Manufacture Date 10/10/2012; Lot Code Y102612-12,  ...
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Class II ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the lead wire filaments and potentially render the device incapable of delivering the appropriate energy or shock to the patient and/or could cause potential injury to user or patient. ConMed Corporation
Food Senora Verde Taco Dinner Kit, 12ct, 9.75 oz (276g), 12 cartons per case. DA OCT 29 13 A 09:37 Class II The incorrect taco seasoning pouch, which contained wheat, was placed into the Senora Verde Taco Dinner Kit, which didn't declare wheat, so the product contained undeclared wheat. Gruma Corp
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