Why it was recalled
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
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
Lot numbers, UPCs & expiration codes
Lot # 197
Where it was sold
OH, MS, IN
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0720-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2021
- FDA report date
- Aug 18, 2021
- Quantity
- 36,540 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eli Lilly & Company
Original FDA data
Every field from FDA enforcement report D-0720-2021, exactly as published.
Show all FDA fields
- City
- Indianapolis
- State
- IN
- Status
- Terminated
- Country
- United States
- Event ID
- 88193
- Address
- 839 S Delaware St
- Code information
- Lot # 197
- Postal code
- 46225-1782
- Report date
- Aug 18, 2021
- Product type
- Drugs
- Recall number
- D-0720-2021
- Classification
- Class II
- Recalling firm
- Eli Lilly & Company
- Product quantity
- 36,540 vials
- Termination date
- Jul 29, 2023
- Reason for recall
- cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- OH, MS, IN
- Recall initiation date
- Jun 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 11, 2021