FDAFDA · Food and drugs·Recall number D-0067-2021
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Published November 11, 2020 · Recall initiated: October 23, 2020
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 · Letter
Recall details
- Manufacturer
- Nostrum Laboratories Inc
- Distributor
- Nationwide
- Lot
- MET200101, MET200301 EXP 05/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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