Drug product

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-90

D-1393-2020

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-1393-2020

Official wording

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

Code information: HB10019A 03-2021 HB10119A 03-2021 HB10219A 03-2021 HB10319A 03-2021 HD02119A 04-2021 HD03319A 04-2021 HF09118A 06-2020 HF11618A 06-2020 HF15218A 07-2020 HF15318A 07-2020 HJ01418A 09-2020 HJ01518A 09-2020 HJ01618A 09-2020 HJ01718A 09-2020 HJ04718A 09-2020 HK03218A 10-2020 HK03318A 10-2020 HK03418A 10-2020 HK03518A 10-2020 HK03618A 10-2020 HK13718A 11-2020 HK13818A 11-2020 HK13918A 11-2020 HK14018A 11-2020 HK14118A 11-2020 HK14218A 11-2020 HK14318A 11-2020 HK14418A 11-2020 HK14518A 11-2020 HM00118A 11-2020

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