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 III
Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4 by AVKARE Inc.
Reason
Labeling: Label Error on Declared Strength Published
August 17, 2022 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13 by AVKARE Inc.
Reason
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. Published
June 23, 2021 Distribution
Distributed in Los Angeles California
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FDA Recall
Terminated
Historical record Class I
TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10 by AVKARE Inc.
Reason
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. Published
December 23, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01. by AVKARE Inc.
Reason
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. Published
December 23, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 NDC 42291-564-12 by AVKARE Inc.
Reason
Failed Dissolution Specifications Published
November 18, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15); b) 90 count (NDC 42291-610-90); c) 180 count (NDC 42291-610-18); d) 360 count (NDC 42291-610-36); e) 1000 count (NDC 42291-610-10) bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 by AVKARE Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Published
June 24, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-18) c) 500 count (NDC 42291-611-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 by AVKARE Inc.
Reason
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Published
June 24, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class III
Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50, Manufactured for: AvKARE, Inc. Pulaski, TN 38478. by AVKARE Inc.
Reason
Presence of Foreign Substance consistent with granules from desiccant packs used during storage Published
June 10, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-282-13. by AVKARE Inc.
Reason
Failed Impurities/Degradation Specifications: High out of specification results for related compounds. Published
January 22, 2020 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30 by AVKARE Inc.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Published
December 4, 2019 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-60 by AVKARE Inc.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Published
December 4, 2019 Distribution
Nationwide
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FDA Recall
Terminated
Historical record Class II
AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 by AVKARE Inc.
Reason
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Published
November 6, 2019 Distribution
CO and MO
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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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