Drug product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
D-0121-2020
Product summary
- Event
- Event 83840
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,688 bottles
- Official record key
drug-enforcement:D-0121-2020
Official wording
Reason: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Code information: Lot 4DU2E009
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations