Eli Lilly & Company: Drug Recall

Recall #D-0720-2021 · 06/29/2021

Class II: Risk

Recall Details

Recall Number: D-0720-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Eli Lilly & Company
Status: Terminated
Date Initiated: 06/29/2021
Location: Indianapolis, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 36,540 vials

Reason for Recall

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

Distribution Pattern

OH, MS, IN

Other Recalls by Eli Lilly & Company

Class II: Risk 03/12/2024

CGMP Deviations
Class I: Dangerous 09/24/2021

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II: Risk 08/19/2021

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.

View all recalls by Eli Lilly & Company →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.