Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indian
Summary
The FDA issued a Class II for Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx o by Eli Lilly & Company. Reason: cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product..
Details
Source
Drug Recall
External ID
D-0720-2021
Action Date
2021-08-18
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 197
Quantity Affected: 36,540 vials
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-29
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eli Lilly & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eli Lilly & Company have FDA actions?
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0720-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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