FDAFDA · Food and drugs·Recall number D-0227-2021
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 January 20, 2021 · Recall initiated: January 4, 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 · Press Release
Recall details
- Manufacturer
- Nostrum Laboratories Inc
- Distributor
- Nationwide
- Lot
- MET200501 07/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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