Drug product
Metformin HCL E/R 500 mg, 90 Tabs, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 72189-064-90
D-0058-2021
Product summary
- Firm
- Direct Rx
- Event
- Event 86601
- Status
- Terminated
- Classification
- Class II
- Quantity
- 88 bottles
- Official record key
drug-enforcement:D-0058-2021
Official wording
Reason: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Code information: Lot: 04DE1902, 11DE1908 Exp. 06/30/2021
Distribution pattern: FL
Derived failure modes
-
Foreign material or chemical contamination
NDMA) impurity
-
Manufacturing or process control
CGMP Deviations