Drug product
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
D-0720-2021
Product summary
- Event
- Event 88193
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36,540 vials
- Official record key
drug-enforcement:D-0720-2021
Official wording
Reason: cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Code information: Lot # 197
Distribution pattern: OH, MS, IN
Derived failure modes
-
Manufacturing or process control
cGMP deviations