Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-1348-2020

D-1348-2020 Class II Ongoing

Recalled by Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY

Recall Details

Product Type
Drugs
Report Date
July 1, 2020
Initiation Date
May 29, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg Rx only 100 Tablets bottles, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-01

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

HF02318A 6/30/2020 HF02418A 6/30/2020 HF02518A 6/30/2020 HF07718A 6/30/2020 HH02118A 7/31/2020 HM04418A 12/31/2020 HM04518A 12/31/2020 HM04618A 12/31/2020 HM04718A 12/31/2020 HM05518A 12/31/2020 HM05618A 12/31/2020 HM05718A 12/31/2020 HM05818A 12/31/2020 HM05918A 12/31/2020 HM06018A 12/31/2020

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