Medications & Supplements/Prescription Drugs

Fyremadel (Ganirelix Acetate) Injection Recalled for Glass Particles

Agency Publication Date: April 27, 2023

Summary

Sun Pharmaceutical Industries Ltd. has recalled 24,194 prefilled syringes of Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL. The recall was initiated because a piece of glass was found inside a prefilled syringe. While no injuries have been reported, consumers should contact their healthcare provider or pharmacist regarding the use of this medication.

Risk

The presence of glass particles in an injectable medication poses a serious risk of local irritation, inflammation, or damage to blood vessels if the contaminated solution is administered.

What You Should Do

This recall affects Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, sold in single-dose sterile prefilled syringes (NDC 55566-1010-1) distributed by Ferring Pharmaceuticals Inc.
Check the medication carton or syringe for lot number HAD1190A with an expiration date of 02/2024 to determine if your product is part of the recall.
If you have health concerns after using this medication, contact your healthcare provider or pharmacist immediately.
Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Ltd. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fyremadel (ganirelix acetate) injection

Variants: 250 mcg/0.5 mL, 0.5 mL Single Dose Sterile Prefilled Syringe

Lot Numbers:

HAD1190A (Exp. 02/2024)

NDC:

55566-1010-1

Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92140

Status: Resolved

Manufacturer: Sun Pharmaceutical Industries Ltd.

Sold By: Ferring Pharmaceuticals Inc.; Pharmacies

Manufactured In: India

Units Affected: 24194 Prefilled Syringes

Distributed To: Nationwide

Agency Last Updated: May 10, 2023

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

This recall affects Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, sold in single-dose sterile prefilled syringes (NDC 55566-1010-1) distributed by Ferring Pharmaceuticals Inc.

Check the medication carton or syringe for lot number HAD1190A with an expiration date of 02/2024 to determine if your product is part of the recall.

If you have health concerns after using this medication, contact your healthcare provider or pharmacist immediately.

Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries Ltd. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional assistance.