Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
June 24, 2020DrugsFDA
AVKARE Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-
Hazard: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
June 10, 2020DrugsFDA
AVKARE Inc. recalls Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,
Hazard: Presence of Foreign Substance consistent with granules from desiccant packs used during storage
January 22, 2020DrugsFDA
AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski
Hazard: Failed Impurities/Degradation Specifications: High out of specification results for related compounds.
December 4, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
December 4, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal P
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
November 6, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for:
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
November 6, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for:
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
September 18, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Hazard: Failed Stability Specifications.
May 8, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-516-15 Manufactured for: AvKARE Inc.
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
May 8, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
April 17, 2019DrugsFDA
AVKARE Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --
Hazard: Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufa
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufac
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 27, 2019DrugsFDA
AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski,
Hazard: CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
March 20, 2019DrugsFDA
AVKARE Inc. recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-
Hazard: Failed Dissolution Specifications
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
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulask
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
September 5, 2018DrugsFDA
AVKARE Inc. recalls Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
April 25, 2018DrugsFDA
AVKARE Inc. recalls Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN
Hazard: Failed Dissolution Specifications
January 24, 2018DrugsFDA
AVKARE Inc. recalls Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38
Hazard: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
November 8, 2017DrugsFDA
AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828
Hazard: Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
August 23, 2017DrugsFDA
AVKARE Inc. recalls Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38
Hazard: Failed impurities/degradation specifications: Out of specification for a related compound C.
March 29, 2017DrugsFDA
AVKARE Inc. recalls Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski,
Hazard: Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
March 11, 2015DrugsFDA
AVKARE Inc. recalls Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN
Hazard: Subpotent Drug
March 11, 2015DrugsFDA
AVKARE Inc. recalls Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 3
Hazard: Subpotent Drug