Drug product

amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11

D-1353-2020

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-1353-2020

Official wording

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

Code information: HF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020

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