Drug product
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30
D-1314-2020
Product summary
- Event
- Event 85756
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13322 bottles
- Official record key
drug-enforcement:D-1314-2020
Official wording
Reason: Failed Impurities/ Degradation Specifications
Code information: Lot #: 561180046A1, Exp 8/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Unknown
Failed Impurities/ Degradation Specifications