Drug product
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
D-0154-2025
Product summary
- Event
- Event 95838
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,744 30-count bottles
- Official record key
drug-enforcement:D-0154-2025
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot# BOB12318A Exp 07/31/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications