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FDAFDA · Food and drugs·Recall number D-0249-2021

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

Published February 10, 2021 · Recall initiated: January 25, 2021

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Nostrum Laboratories Inc
Distributor
Nationwide
Lot
Lot MET200601, 07/2022
Risk classification
Class II
Area (FDA)
drug
Country
United States

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