Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2013-05-29FDA-DrugLloyd Inc. of IowaClass IILloyd Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
- 2013-05-29FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP) , 75 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1322-01
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
- 2013-05-29FDA-DrugLloyd Inc. of IowaClass IILloyd Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums (2/75,000-tablet bags/drum) for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
- 2013-05-29FDA-DrugLloyd Inc. of IowaClass IILevothroid (levothyroxine sodium tablets, USP) , 50 mcg, RX only, 100 tablets per bottle, Manufactured for Forest Pharmaceuticals, Inc, St. Louis, MO by Lloyd Pharmaceutical, Shenandoah, IA, NDC 0456-1321-01
cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles (NDC 60793-860-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles (NDC 60793-859-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles (NDC 60793-858-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles (NDC 60793-857-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles (NDC 60793-856-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles (NDC 60793-855-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles (NDC 60793-854-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 88 mcg, packaged in a) 100-count bottles (NDC 60793-853-01) and b) 1000-count bottles (NDC 60793-853-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 75 mcg, packaged in a) 100-count bottles (NDC 60793-852-01) and b) 1000-count bottles (NDC 60793-852-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 50 mcg, packaged in a) 100-count bottles (NDC 60793-851-01) and b) 1000-count bottles (NDC 60793-851-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugKing Legacy, a wholly owned subsidiary of PfizerClass IILevoxyl (levothyroxine sodium) tablets, USP, 25 mcg, packaged in a) 100-count bottles (NDC 60793-850-01) and b) 1000-count bottles (NDC 60793-850-10), Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Subpotent Drug: The products were below specification for potency at the expiry stability point.
- 2013-05-29FDA-DrugNovartis Consumer HealthClass IIILamisil AT (terbinafine hydrochloride cream 1% antifungal), 24 g (.85 oz) tube, Novartis Consumer Health, Parsippany, NJ 07054, NDC 0067-6171-85
Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.
- 2013-05-29FDA-DrugAaron Industries IncClass IIIRite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10 mg, guaifenesin 200 mg and phenylephrine HCl 5 mg), 4 oz. package size, Distributed by: Rite Aid, Camp Hill, PA --- UPC Code: 0 11822 57307 8.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
- 2013-05-22FDA-DrugHi-Tech Pharmacal Co., Inc.Class IIIBUCALSEP (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
Subpotent; Cetylpyridinum Chloride
- 2013-05-22FDA-DrugNuVision Pharmacy, Inc.Class IIMethylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
Lack of Assurance of Sterility; reports of adverse events after injection
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IIZinc 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IITriamcinolone 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IIThiamine 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IITestosterone 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 8
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IITestosterone 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IITaurine 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IITestosterone 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IISodium 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IISodium 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IISodium 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.
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.
- 2013-05-22FDA-DrugFVS Holdings, Inc. dba. Green Valley DrugsClass IINandrolone 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.
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.
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