AVKARE Inc. Recalls Recalls by year
A bar chart of the number of recalls naming this company by year.
Recalls by year
Year Recalls 2015 2 2017 3 2018 7 2019 12 2020 7 2021 1 2022 1
Download CSV FDA Recall
Terminated
Historical record Class II
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 by AVKARE Inc.
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Published
September 5, 2018 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478 by AVKARE Inc.
Reason
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Published
September 5, 2018 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15 by AVKARE Inc.
Reason
Failed Dissolution Specifications Published
April 25, 2018 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15. by AVKARE Inc.
Reason
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing. Published
January 24, 2018 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15. by AVKARE Inc.
Reason
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. Published
November 8, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12 by AVKARE Inc.
Reason
Failed impurities/degradation specifications: Out of specification for a related compound C. Published
August 23, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13 by AVKARE Inc.
Reason
Failed impurities/ degradation specifications: Product was above specification for unknown impurities. Published
March 29, 2017 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15 by AVKARE Inc.
Reason
Subpotent Drug Published
March 11, 2015 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15 by AVKARE Inc.
Reason
Subpotent Drug Published
March 11, 2015 Distribution
Nationwide
View recall →
This page lists recalls that name AVKARE Inc. as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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