Drug product

amneal Metformin Hydrochloride Extended-Release Tablets, USP, Bulk, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0179-BULK

D-1354-2020

May 29, 2020

Class II

Product summary

Firm: Amneal Pharmaceuticals of New York, LLC
Event: Event 85781
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-1354-2020

Official wording

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

Code information: HA01520A 1/31/2021 HA01620A 1/31/2021 HG01719A 7/31/2020 HG01819A 7/31/2020 HH09319A 8/31/2020 HH09419A 9/30/2020 HK07619A 10/31/2020 HK07719A 10/31/2020

Distribution pattern: Nationwide

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

NDMA) impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations