Medications & Supplements/Prescription Drugs

EMD Serono, Inc.: Cetrotide Injection Recalled for Missing Rubber Stoppers and Sterility Risk

Agency Publication Date: July 8, 2020

Summary

EMD Serono, Inc. is recalling approximately 30,756 vials of Cetrotide (cetrorelix acetate for injection) 0.25 mg. This prescription medication is used for subcutaneous injection and is being recalled because of market complaints reporting that rubber stoppers are missing from the drug vials. Without the rubber stopper, the manufacturer cannot guarantee the sterility of the medication, which may have been compromised during distribution or storage.

Risk

A missing rubber stopper creates an open pathway for bacteria or other contaminants to enter the vial, leading to a lack of sterility assurance. Injecting a non-sterile medication can cause serious infections or other adverse health reactions at the injection site or throughout the body.

What You Should Do

Immediately check your medication supply for Cetrotide (cetrorelix acetate for Injection) 0.25 mg vials with NDC 44087-1225-1.
Verify if your medication is part of the affected lots by looking for Lot numbers 8J025A or 8J025B with an expiration date of 09/30/2020.
Visually inspect the vials for a missing rubber stopper; however, even if the stopper appears present, do not use any vials from the affected lots.
Contact your healthcare provider or pharmacist immediately for guidance if you have used the affected product or need a replacement prescription.
Return any unused vials from these lots to your pharmacy for a refund and contact EMD Serono, Inc. at 1-888-723-3332 for further instructions.
For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cetrotide (cetrorelix acetate for Injection) 0.25 mg

Model:

NDC: 44087-1225-1

Lot Numbers:

8J025A (Exp 09/30/2020)

8J025B (Exp 09/30/2020)

Date Ranges: Exp 09/30/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85938

Status: Resolved

Manufacturer: EMD Serono, Inc.

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 30,756 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your medication supply for Cetrotide (cetrorelix acetate for Injection) 0.25 mg vials with NDC 44087-1225-1.

Verify if your medication is part of the affected lots by looking for Lot numbers 8J025A or 8J025B with an expiration date of 09/30/2020.

Visually inspect the vials for a missing rubber stopper; however, even if the stopper appears present, do not use any vials from the affected lots.

Contact your healthcare provider or pharmacist immediately for guidance if you have used the affected product or need a replacement prescription.

Return any unused vials from these lots to your pharmacy for a refund and contact EMD Serono, Inc. at 1-888-723-3332 for further instructions.

For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.