Drug product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
D-0032-2021
Product summary
- Firm
- Direct Rx
- Event
- Event 86487
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33 bottles
- Official record key
drug-enforcement:D-0032-2021
Official wording
Reason: CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Code information: Lot: 12DE1806 Exp. 01/31/2021
Distribution pattern: FL
Derived failure modes
-
Foreign material or chemical contamination
impurity detected to be N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP deviation