August 15, 2018DrugsFDA
Pharmalucence, Inc. recalls Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1)
Hazard: Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
August 15, 2018DrugsFDA
NuCare Pharmaceuticals Inc recalls Valsartan/HCTZ 320/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 15, 2018DrugsFDA
NuCare Pharmaceuticals Inc recalls Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 15, 2018DrugsFDA
NuCare Pharmaceuticals Inc recalls Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, N
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 15, 2018DrugsFDA
Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag,
Hazard: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
August 15, 2018DrugsFDA
Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag,
Hazard: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
August 15, 2018DrugsFDA
Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx
Hazard: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
August 8, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 5 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Hazard: Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
August 8, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible
Hazard: Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
August 8, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible
Hazard: Failed Stability Specifications: lot out of specification for elevated water vapor.
August 8, 2018DrugsFDA
Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible
Hazard: Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
August 8, 2018DrugsFDA
Bryant Ranch Prepack Inc. recalls Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
Bryant Ranch Prepack Inc. recalls Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (N
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
Bryant Ranch Prepack Inc. recalls Valsartan 80 mg tablets, 90-count bottles (NDC 63629-6922-2), 60-count bottles ( 63629-6922-3), 28-count bottles (63629-
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
MAJOR PHARMACEUTICALS recalls Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceutic
Hazard: Failed Dissolution Specifications
August 8, 2018DrugsFDA
West-Ward Columbus Inc recalls Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. E
Hazard: Failed Dissolution Specifications:
August 8, 2018DrugsFDA
West-Ward Columbus Inc recalls Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Ea
Hazard: Failed Dissolution Specifications:
August 8, 2018DrugsFDA
PFIZER recalls Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Fores
Hazard: Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
August 8, 2018DrugsFDA
H J Harkins Company Inc dba Pharma Pac recalls Valsartan tablets 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 4354
Hazard: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 1570
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 157
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Indomethacin Capsules, USP, 50 mg, 100-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscatawa
Hazard: Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
August 8, 2018DrugsFDA
VENSUN PHARMACEUTICALS INC recalls Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceut
Hazard: Failed Tablet/Capsule Specifications: Tablet breakage
August 8, 2018DrugsFDA
VENSUN PHARMACEUTICALS INC recalls Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceut
Hazard: Failed Tablet/Capsule Specifications: Tablet breakage
August 1, 2018DrugsFDA
Aidarex Pharmaceuticals LLC recalls Enalapril Maleate, USP 5MG, 30-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.
Hazard: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
August 1, 2018DrugsFDA
Aidarex Pharmaceuticals LLC recalls Enalapril Maleate, USP 5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.
Hazard: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
August 1, 2018DrugsFDA
Aidarex Pharmaceuticals LLC recalls Enalapril Maleate, USP 2.5MG, 90-count bottle, RX only. Packaged By: Aidarex Pharmaceuticals. Mfg: Wockhardt Ltd. India.
Hazard: Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Onl
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.