Zyprexa Injection, Powder, For Solution
FDA Recall NDC 0002-7597
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zyprexa (NDC 0002-7597). A significant event, classified as Class II, was initiated on Jun 29, 2021 by Eli Lilly And Company. The reported reason for this action was: "cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Jun 29, 2021
Aug 18, 2021
36,540 vials
Recall Profile & Regulatory Data
Event ID
88193
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Eli Lilly & Company
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH, MS, IN
Termination Date
Jul 29, 2023
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
Batch or Lot Expiration Information
Lot# 197
Affected Packages Involved in this Recall
0002-4112-30Product
0002-4115-30Product
0002-4116-30Product
0002-4117-30Product
0002-4415-30Product
0002-4420-30Product
0002-4453-01Product
0002-4453-85Product
0002-4454-01Product
0002-4454-85Product
0002-4455-01Product
0002-4455-85Product
0002-4456-01Product
0002-4456-85Product
0002-7597-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
