Drug 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
D-0569-2023
Product summary
- Event
- Event 92140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24194 Prefilled Syringes
- Official record key
drug-enforcement:D-0569-2023
Official wording
Reason: Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Code information: Lot #: HAD1190A, Exp. 02/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter