February 27, 2003
Serono Laboratories Has Recalled Gonal-F
The Food and Drug
Administration (FDA) released the following information.
Gonal-F (follitropin alfa for injection) 1200 IU Multi-dose vial for
injection copackaged with one pre-filled syringe containing 2 mL
Bacteriostatic Water for Injection, USP, Rx Only, For subcutaneous use, NDC
Recall # D-123-3.
Gonal F lot numbers: BK006A, BK007A, BK008B, BK009A, BK010B, BK012A, BK013A
(Prefilled Syringe Diluent Lot Numbers: 1-BEX-701, 1-BEX-702, and
Serono Laboratories, Inc, Rockland, MA, by letter dated November 21, 2002.
Firm initiated recall ongoing.
Lack of assurance of sterility for the copackaged pre-filled diluent
syringes(manufactured by Schering Plough Corporation) copackaged with Gonal-F.
VOLUME OF PRODUCT IN COMMERCE