Drug product
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.
D-0639-2022
Product summary
- Event
- Event 89607
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3672 bottles
- Official record key
drug-enforcement:D-0639-2022
Official wording
Reason: cGmp Deviations
Code information: Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGmp Deviations