Cetrotide Kit
FDA Recall NDC 44087-1225
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 Cetrotide (NDC 44087-1225). A significant event, classified as Class II, was initiated on Jun 29, 2020 by Emd Serono, Inc.. The reported reason for this action was: "Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance."
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
Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
Jun 29, 2020
Jul 15, 2020
30,756 vials
Recall Profile & Regulatory Data
Event ID
85938
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
EMD Serono, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Mar 11, 2022
Product Description
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
Batch or Lot Expiration Information
Lot# 8J025A; 8J025B, Exp 09/30/2020
Affected Packages Involved in this Recall
44087-1225-1Product
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.
