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, NDC #: 68788-6932-1, Preferred Pharmaceuticals, Inc.
- Company
- Preferred Pharmaceuticals, Inc.
- Recall Initiated
- November 1, 2020
- Posted
- November 25, 2020
- Recall Number
- D-0077-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 99 bottles (9990 Extended Release Tablets)
- 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
Distributed to two physician's offices located in FL.
Lot / Code Info
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
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