Fyremadel injection recalled over possible glass fragments

Recall date

April 19, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sun Pharmaceutical Industries Ltd. recalls Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutan…

Recall number

D-0569-2023

FDA classification

Class II

Brand / firm

Sun Pharmaceutical Industries Ltd.

Sold / distributed

Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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