Drug product
Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by RemedyRepack, Inc. Indiana, PA, 15701-3570, NDC 70518-1560-00.
D-1270-2019
Product summary
- Event
- Event 82748
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 HDPE bottles of 90 = 3,960 tablets
- Official record key
drug-enforcement:D-1270-2019
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 0.96 parts per million.
Code information: Lot #: B0517068-101618, Exp. Date: 10/2019
Distribution pattern: Product was distributed to Florida.
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-Methylnitrosobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations