FDAFDA · Food and drugs·Recall number D-1364-2020
Metformin HCl Extended Release Tablets, USP, 500 mg, Generic for Glucophage XR, Pkg Size 100, Mfg: Time-Cap, Labs Inc., Farmingdale, NY, Preferred Pharmaceuticals, Anaheim, CA NDC: 68788-6932-01
Published July 8, 2020 · Recall initiated: June 17, 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
- Product was distributed to two medical clinics located in FL.
- Lot
- J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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