FDA recall D-0392-2022

VIONA PHARMACEUTICALS INC · Class II · drug

Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01

Reason for recall

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

Distribution

Product was distributed to 17 wholesalers who further distributed the product to 85 locations.

Key facts

Status
Terminated
Initiation date
2021-12-27
Report date
2022-02-02
Termination date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Cranford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0392-2022