FDA recall D-0227-2021

Product

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01

Reason for recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

Distribution

Nationwide

Key facts

Status

Ongoing

Initiation date

2021-01-04

Report date

2021-01-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Kansas City, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0227-2021