Home / Recalls / Amneal Pharmaceuticals of New York, LLC / D-1351-2020

D-1351-2020 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, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

HF06618A 6/30/2020 HF06718A 6/30/2020

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