Drug product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-44
D-0498-2024
Product summary
- Event
- Event 94592
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,048 bottles
- Official record key
drug-enforcement:D-0498-2024
Official wording
Reason: Presence of foreign substance: plastic-like substance.
Code information: Lot #: BLK2304A, Exp. 07/31/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Foreign material or chemical contamination
foreign substance