Class II
Terminated
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
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- June 17, 2020
- Posted
- July 8, 2020
- Recall Number
- D-1364-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 144 bottles
- Firm Location
- Anaheim, CA, United States
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution
Product was distributed to two medical clinics located in FL.
Lot / Code Info
J0119M, K1419L, K2719J, A0220H; Exp. Date 12/2020
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