FDAFDA · Food and drugs·Recall number D-0077-2021
Metformin HCl Extended Release Tablets USP 500 mg, Generic for : Glucophage XR, Pkg Size 100, Mfg: Time-Cap Labs, Inc.; Farmingdale, NY, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
Published November 25, 2020 · Recall initiated: November 1, 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: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- Distributed to two physician's offices located in FL.
- Lot
- E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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