FDA recall D-1360-2020

Product

Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61

Reason for recall

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2020-06-12

Report date

2020-07-08

Termination date

2022-09-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1360-2020