Medications & Supplements/Prescription Drugs

SUN PHARMACEUTICAL INDUSTRIES INC: Ganirelix Acetate Injection Recalled for Impurity Specification Failure

Agency Publication Date: April 2, 2021

Summary

Sun Pharmaceutical Industries Inc. has voluntarily recalled 91,211 syringes of Ganirelix Acetate Injection (250 mcg/0.5 mL) because the product failed to meet specific impurity and degradation standards. This prescription medication, used during fertility treatments, was distributed by Ferring Pharmaceuticals and manufactured in India. If you have this medication, you should contact your healthcare provider or pharmacist for guidance on how to proceed.

Risk

The drug failed to meet quality specifications for impurities and degradation, which means the medication may contain higher-than-approved levels of chemical breakdown products that could potentially affect the drug's safety or efficacy.

What You Should Do

Check your medication packaging for Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringes with NDC 55566-1000-1.
Verify the lot numbers and expiration dates on the prefilled syringes: Look for lot numbers JKU1212A, JKU1503A, JKU1504A, JKU1505A, or JKU1506A with an expiration date of 03/2021, or lot numbers JKU3313A or JKU3314A with an expiration date of 08/2021.
Contact your healthcare provider or pharmacist immediately for guidance if you find you have an affected syringe.
Return any unused, affected product to the pharmacy or place of purchase for a refund.
Contact Sun Pharmaceutical Industries Inc. at their Princeton, NJ location or via the distributor, Ferring Pharmaceuticals, for further instructions regarding this recall.
For additional questions or to report a problem, 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

Pharmacy refund

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

Affected Products

Product: Ganirelix Acetate Injection (250 mcg/0.5 mL)

Model:

NDC 55566-1000-1

Lot Numbers:

JKU1212A (Exp 03/2021)

JKU1503A (Exp 03/2021)

JKU1504A (Exp 03/2021)

JKU1505A (Exp 03/2021)

JKU1506A (Exp 03/2021)

JKU3313A (Exp 08/2021)

JKU3314A (Exp 08/2021)

Date Ranges: Expiration March 2021, Expiration August 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87545

Status: Resolved

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Ferring Pharmaceuticals, Inc.

Manufactured In: India, United States

Units Affected: 91,211 syringes

Distributed To: New Jersey

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

Check your medication packaging for Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringes with NDC 55566-1000-1.

Verify the lot numbers and expiration dates on the prefilled syringes: Look for lot numbers JKU1212A, JKU1503A, JKU1504A, JKU1505A, or JKU1506A with an expiration date of 03/2021, or lot numbers JKU3313A or JKU3314A with an expiration date of 08/2021.

Contact your healthcare provider or pharmacist immediately for guidance if you find you have an affected syringe.

Return any unused, affected product to the pharmacy or place of purchase for a refund.

Contact Sun Pharmaceutical Industries Inc. at their Princeton, NJ location or via the distributor, Ferring Pharmaceuticals, for further instructions regarding this recall.

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

Affected Products

Product: Ganirelix Acetate Injection (250 mcg/0.5 mL)

Model:

NDC 55566-1000-1

Lot Numbers:

JKU1212A (Exp 03/2021)

JKU1503A (Exp 03/2021)

JKU1504A (Exp 03/2021)

JKU1505A (Exp 03/2021)

JKU1506A (Exp 03/2021)

JKU3313A (Exp 08/2021)

JKU3314A (Exp 08/2021)

Date Ranges: Expiration March 2021, Expiration August 2021