FDA-Drug2021-04-14Class II

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.

SUN PHARMACEUTICAL INDUSTRIES INC
Hazard

Failed Impurities/Degradation Specifications

Sold states
NJ
Affected count
91,211 syringes
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2021

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