FDA recall D-0320-2021

Product

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

Distribution

NJ

Key facts

Status

Terminated

Initiation date

2021-03-15

Report date

2021-04-14

Termination date

2023-06-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

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