RecallDepth
Class II Ongoing

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

Company
Nostrum Laboratories Inc
Recall Initiated
January 25, 2021
Posted
February 10, 2021
Recall Number
D-0249-2021
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
7071 bottles
Firm Location
Kansas City, MO, United States

Reason for Recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Distribution

Nationwide

Lot / Code Info

Lot MET200601, 07/2022

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