FDA recall D-0640-2021

Product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 NDC 72578-036-01

Reason for recall

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

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2021-06-01

Report date

2021-06-30

Termination date

2023-05-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2021