FDA recall D-0366-2022

Product

Metformin 750 mg Extended Release NDC # 70518-2920-00

Reason for recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Distribution

Product was distributed to one direct account in PA.

Key facts

Status

Terminated

Initiation date

2021-12-30

Report date

2022-01-19

Termination date

2022-03-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0366-2022