PlainRecalls
FDA Drug Moderate Class II Terminated

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

Reported: April 14, 2021 Initiated: March 15, 2021 #D-0320-2021

Product Description

Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Units Affected
91,211 syringes
Distribution
NJ
Location
Princeton, NJ

Frequently Asked Questions

What product was recalled?
Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 91,211 syringes.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on April 14, 2021. Severity: Moderate. Recall number: D-0320-2021.