PlainRecalls
FDA Drug Moderate Class II Terminated

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

Reported: May 3, 2023 Initiated: April 19, 2023 #D-0569-2023

Product Description

Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1

Reason for Recall

Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.

Details

Units Affected
24194 Prefilled Syringes
Distribution
Nationwide in the USA
Location
Halol, N/A

Frequently Asked Questions

What product was recalled?
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1. Recalled by Sun Pharmaceutical Industries Ltd.. Units affected: 24194 Prefilled Syringes.
Why was this product recalled?
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 3, 2023. Severity: Moderate. Recall number: D-0569-2023.