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Showing 1181–1200 of 1571 results

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Metformin HCL Extended-Release 500mg (Nostrum) – NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Class IIModerate

FDAOct 23, 2020Nationwide• Nostrum Laboratories Inc

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Metformin Hydrochloride Extended-Release (Denton Pharma) - NDMA Impurity (2020)

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)

Class IIModerate

FDAOct 8, 2020Nationwide• Denton Pharma, Inc.

Elitek Injection (Sanofi-Aventis) - Stability Failure (2020)

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Class IIModerate

FDAAug 10, 2020Nationwide• Sanofi-Aventis U.S. LLC

Assured Vitamin E Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Metformin Hydrochloride Extended-Release 750mg (Granules) – NDMA Impurity (2020)

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

Class IIModerate

FDAJul 3, 2020Nationwide• Granules Pharmaceuticals Inc

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 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

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

Mencaine Patch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

Lidocaine Cold & Hot Patch (Wuhan Bingbing) – Manufacturing Records Lost (2020)

CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.

Class IIModerate

FDAMay 19, 2020Nationwide• Wuhan Bingbing Pharmaceutical Co., Ltd.

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