FDA-Drug2021-06-30Class II
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
VIONA PHARMACEUTICALS INC
Hazard
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Sold states
Nationwide in the US
Affected count
21240 bottles
Manufactured in
20 Commerce Dr Ste 340, N/A, Cranford, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0640-2021Don't want to check this manually?
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