Drug product
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.
D-0077-2021
Product summary
- Event
- Event 86696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 bottles (9990 Extended Release Tablets)
- Official record key
drug-enforcement:D-0077-2021
Official wording
Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Code information: E0620F, Exp.12/31/2021; G2020M Exp., 04/30/2022
Distribution pattern: Distributed to two physician's offices located in FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations