PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 18, 2021 Initiated: June 29, 2021 #D-0720-2021

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.

Details

Recalling Firm
Eli Lilly & Company
Units Affected
36,540 vials
Distribution
OH, MS, IN
Location
Indianapolis, IN

Frequently Asked Questions

What product was recalled?
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. Recalled by Eli Lilly & Company. Units affected: 36,540 vials.
Why was this product recalled?
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 18, 2021. Severity: Moderate. Recall number: D-0720-2021.