Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by:...

FDA Recall #D-0720-2021 — Class II — June 29, 2021

Recall #D-0720-2021 Date: June 29, 2021 Classification: Class II Status: Terminated

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.

Recalling Firm

Eli Lilly & Company — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

36,540 vials

Distribution

OH, MS, IN

Code Information

Lot # 197

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated