December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP,10 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pha
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/320 mg/25 mg, (a) 30-count bottles (NDC 0093-7809-56) & 90
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/25 mg, (a) 30-count bottles (NDC 0093-7960-56) & 90
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 10 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7810-56) & 9
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets 5 mg/160 mg/12.5 mg, (a) 30-count bottles (NDC 0093-7807-56) &
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 10 mg/320 mg (a) 30-count bottles (NDC 0093-7693-56) & 90-count bottles (NDC 0093-7693
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 5 mg/320 mg, (a) 30-count bottles (NDC 0093-7692-56) & 90-count bottles (NDC 0093-7692-
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 10 mg/160 mg, (a) 30-count bottles (NDC 0093-7961-56) & 90-count bottles (NDC 0093-7691
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-
Hazard: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
December 19, 2018DrugsFDA
Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Ma
Hazard: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
December 19, 2018DrugsFDA
Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Ma
Hazard: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
December 19, 2018DrugsFDA
Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Man
Hazard: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
December 19, 2018DrugsFDA
LGM Pharma LLC recalls Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1
Hazard: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
December 19, 2018DrugsFDA
QuVa Pharma, Inc. recalls Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma
Hazard: Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
December 19, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laborato
Hazard: Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.
December 19, 2018DrugsFDA
CAO Group, Inc. recalls FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4
Hazard: cGMP violations noted during the firm's most recent inspection.
December 19, 2018DrugsFDA
CAO Group, Inc. recalls BeeGentle Honey Flavored Topical Anesthetic, Active ingredient Benzocaine 20%. Packaged in: a) Introductory Kit. Net Qty
Hazard: cGMP violations noted during the firm's most recent inspection.
December 19, 2018DrugsFDA
CAO Group, Inc. recalls SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive
Hazard: cGMP violations noted during the firm's most recent inspection.
December 19, 2018DrugsFDA
CAO Group, Inc. recalls fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Dist
Hazard: cGMP violations noted during the firm's most recent inspection.
December 12, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls SODIUM CHLORIDE INJECTION, USP, 0.9%, 20 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,
Hazard: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
December 12, 2018DrugsFDA
Fresenius Kabi USA, LLC recalls SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals,
Hazard: Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
December 12, 2018DrugsFDA
Aurobindo Pharma USA Inc. recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma USA,
Hazard: Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
December 5, 2018DrugsFDA
Akorn, Inc. recalls Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufact
Hazard: Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
December 5, 2018DrugsFDA
Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
December 5, 2018DrugsFDA
Ascend Laboratories LLC recalls Quetiapine Tablets USP 400 mg, 100 tablet bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013,
Hazard: Presence of Foreign Substance; metal shard found in tablet
December 5, 2018DrugsFDA
AVKARE Inc. recalls Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./222mL refill bags, AvKARE, Inc. Pulaski, TN
Hazard: Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
December 5, 2018DrugsFDA
RemedyRepack Inc. recalls Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Pri
Hazard: Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
December 5, 2018DrugsFDA
ALLERGAN recalls INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose
Hazard: Failed Stability Specification: out of specification for iron content.
November 28, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laborato
Hazard: Failed Dissolution Specification: Out-of-Specification results were observed for dissolution at 18th month stability testing.