VIONA PHARMACEUTICALS INC recalls Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare L
Recalled June 30, 2021 · FDA recall D-0640-2021 · VIONA PHARMACEUTICALS
Hazard
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. · FDA Class II
Units
21240 bottles
Sold at
Nationwide in the US
Description
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
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
Manufacturer(s)
VIONA PHARMACEUTICALS INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →