FDA recall D-1303-2020

Product

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

Reason for recall

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

Distribution

Nationwide.

Key facts

Status

Completed

Initiation date

2020-05-27

Report date

2020-06-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

North York, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1303-2020