FDA recall D-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

Reason for recall

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

Distribution

OH, MS, IN

Key facts

Status

Terminated

Initiation date

2021-06-29

Report date

2021-08-18

Termination date

2023-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0720-2021