D-0077-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2020
- Initiation Date
- November 1, 2020
- Termination Date
- May 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 bottles (9990 Extended Release Tablets)
Product Description
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.
Reason for Recall
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Distribution Pattern
Distributed to two physician's offices located in FL.
Code Information
E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022