Drug & medication recalls Moderate risk

Zyprexa Intramuscular recalled over manufacturing violations

Recall date
June 29, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Eli Lilly & Company recalls Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, India…
Recall number
D-0720-2021
FDA classification
Class II
Brand / firm
Eli Lilly & Company
Sold / distributed
OH, MS, IN

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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

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