Drug product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-10
D-1459-2019
Product summary
- Event
- Event 83151
- Status
- Terminated
- Classification
- Class II
- Quantity
- 142626 bottles (12,836,340 tablets)
- Official record key
drug-enforcement:D-1459-2019
Official wording
Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Code information: BLK719A Sep-19 BLK720A Sep-19 BLK721A Sep-19 BLK722A Sep-19 BLK723A Sep-19 BLK724A Sep-19 BLK725A Oct-19 BLK726A Oct-19 BLK804A Jan-20 BLK806A Jan-20 BLK825A Oct-21 BLK826A Oct-21
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA
-
Manufacturing or process control
CGMP Deviations