FDA Drug · D-0366-2022

Metformin 750 mg Extended Release NDC # 70518-2920-00

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 # J0511265-021121, exp. date 02/28/2022 J0499451-122220, exp. date 01/31/2022 J0496563-120820, exp. date 12/31/2021 J0495111-120120, exp. date 12/31/2021

Recalling firm: RemedyRepack Inc., Indiana, PA
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 56 Blister Cards
Distribution: Product was distributed to one direct account in PA.
Recall initiated: December 30, 2021
Classified: January 11, 2022
Terminated: March 28, 2022
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-0366-2022%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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