FDA recall D-0569-2023

Product

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.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2023-04-19

Report date

2023-05-03

Termination date

2023-12-13

Voluntary/Mandated

N/A

Location

Halol, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0569-2023