FDA recall D-1351-2020

Amneal Pharmaceuticals of New York, LLC · Class II · drug

Product

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

Nationwide

Key facts

Status: Ongoing
Initiation date: 2020-05-29
Report date: 2020-07-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1351-2020