D-0720-2021 Class II Terminated
FDA drug recall D-0720-2021 was initiated by Eli Lilly & Company on June 29, 2021 and is designated Class II. Reason for recall: cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product. The recall status is terminated (terminated July 29, 2023). Affected quantity: 36,540 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- August 18, 2021
- Initiation Date
- June 29, 2021
- Termination Date
- July 29, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 36,540 vials
Product Description
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
Reason for Recall
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Distribution Pattern
OH, MS, IN
Code Information
Lot # 197