FDAFDA · Food and drugs·Recall number D-0058-2021
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
Published November 11, 2020 · Recall initiated: October 12, 2020
Status when published: Terminated — 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 (per manufacturer)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- METFORMIN HYDROCHLORIDE EXTENDED RELEASE
- Manufacturer
- Direct Rx
- Distributor
- FL
- Lot
- Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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