FDAClass IIAugust 18, 2021

Zyprexa Intramuscular recall: CGMP Deviations

Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC#…

Why was Zyprexa Intramuscular recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 197

Product
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC#…
Recalling firm
Eli Lilly & Company
Quantity
36,540 vials
Distribution
OH, MS, IN
Recall date
August 18, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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