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Amneal Pharmaceuticals of New York, LLC

Amneal Pharmaceuticals of New York, LLC Recalls

All product recalls associated with Amneal Pharmaceuticals of New York, LLC.

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Recall Summary

Total Recalls

12

Past Year

0

Class I (Serious)

0

Most Recent

May 2020

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–12 of 12 recalls

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC

Metformin Hydrochloride Extended-Release Tablets (Amneal) – NDMA Impurity (2020)

CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAMay 29, 2020Nationwide• Amneal Pharmaceuticals of New York, LLC