Recalls / Class II
Class IID-0720-2021
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
- Brand name
- Zyprexa
- Generic name
- Olanzapine
- Active ingredient
- Olanzapine
- Route
- Oral
- NDCs
- 0002-4117, 0002-4112, 0002-4115, 0002-4116, 0002-4415, 0002-4420, 0002-4453, 0002-4454, 0002-4455, 0002-4456 +1 more
- FDA application
- NDA020592
- Affected lot / code info
- Lot # 197
Why it was recalled
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Recalling firm
- Firm
- Eli Lilly & Company
- Manufacturer
- Eli Lilly and Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 839 S Delaware St, N/A, Indianapolis, Indiana 46225-1782
Distribution
- Quantity
- 36,540 vials
- Distribution pattern
- OH, MS, IN
Timeline
- Recall initiated
- 2021-06-29
- FDA classified
- 2021-08-11
- Posted by FDA
- 2021-08-18
- Terminated
- 2023-07-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0720-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.