FDA Drug · D-0640-2021

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

Class II · Terminated

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

Affected lots / codes — check yours against thisLot M915601 & M915602, Oct 2021

Recalling firm: VIONA PHARMACEUTICALS INC, Cranford, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 21240 bottles
Distribution: Nationwide in the US
Recall initiated: June 1, 2021
Classified: June 24, 2021
Terminated: May 31, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0640-2021%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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