Drug product
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
D-0789-2022
Product summary
- Event
- Event 90001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets
- Official record key
drug-enforcement:D-0789-2022
Official wording
Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Code information: Lot: E1321O, Exp.: 5/31/2023 Lot: E2521H, Exp.: 5/31/2023 Lot: E2621F, Exp.: 5/31/2023
Distribution pattern: Nationwide within the U.S to CA, IN and FL.
Derived failure modes
-
Foreign material or chemical contamination
AZIDO Impurity
-
Manufacturing or process control
CGMP Deviations