AVKARE Inc. recalls

33 recalls on record · latest: July 20, 2022

Official U.S. recall history for AVKARE Inc., compiled from official government records.

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AVKARE Inc. recalls Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 422…

July 20, 2022 · Drug & medication recalls Labeling: Label Error on Declared Strength

AVKARE Inc. recalls Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-…

June 9, 2021 · Drug & medication recalls Failed Impurities Specification: Out of specification when measuring the impuri…

AVKARE Inc. recalls TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC…

December 7, 2020 · Drug & medication recalls High risk Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged…

AVKARE Inc. recalls Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

December 7, 2020 · Drug & medication recalls Moderate risk Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged…

AVKARE Inc. recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, In…

October 30, 2020 · Drug & medication recalls Moderate risk Failed Dissolution Specifications

Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

June 4, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity a…

Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

June 4, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity a…

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,…

May 28, 2020 · Drug & medication recalls Presence of Foreign Substance consistent with granules from desiccant packs use…

AVKARE Inc. recalls Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulask…

January 7, 2020 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: High out of specification results…

AVKARE Ranitidine Tablets recalled over manufacturing violations

November 14, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Ranitidine Tablets recalled over manufacturing violations

November 14, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE product recalled over manufacturing violations

October 17, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE product recalled over manufacturing violations

October 17, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

AVKARE Inc. recalls AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

August 28, 2019 · Drug & medication recalls Moderate risk Failed Stability Specifications.

AVKARE product recalled over manufacturing violations

April 24, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobuty…

AVKARE product recalled over manufacturing violations

April 24, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobuty…

AVKARE Inc. recalls Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --…

April 3, 2019 · Drug & medication recalls Failed Impurities/Degradation Specifications; 18 month long term stability stud…

Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

March 5, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) wa…

Losartan Potassium Tablets USP 50 mg 50 Tablets Unit Dose boxes recalled over manufacturing violations

March 5, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) wa…

Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

March 5, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) wa…

AVKARE Inc. recalls Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291…

March 1, 2019 · Drug & medication recalls Failed Dissolution Specifications

Germ Bloc Health Hand Sanitizer Foam / refill bags recalled over sterility concerns

November 20, 2018 · Drug & medication recalls Moderate risk Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aerugin…

Valsartan Tablets recalled over manufacturing violations

August 14, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug p…

Valsartan Tablets recalled over manufacturing violations

August 14, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug p…

Valsartan Tablets recalled over manufacturing violations

August 14, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug p…

Valsartan Tablets recalled over manufacturing violations

August 14, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug p…

AVKARE Inc. recalls Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN…

March 30, 2018 · Drug & medication recalls Moderate risk Failed Dissolution Specifications

AVKARE Inc. recalls Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 3…

January 3, 2018 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: Low out of specification results for dissolu…

AVKARE Inc. recalls Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 502682…

October 6, 2017 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications: slightly elevated levels of phtha…

AVKARE Inc. recalls Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 3…

July 19, 2017 · Drug & medication recalls Failed impurities/degradation specifications: Out of specification for a relate…

AVKARE Inc. recalls Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski,…

February 15, 2017 · Drug & medication recalls Moderate risk Failed impurities/ degradation specifications: Product was above specification…

AVKARE Inc. recalls Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN…

February 27, 2015 · Drug & medication recalls Subpotent Drug

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…

February 27, 2015 · Drug & medication recalls Subpotent Drug