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SafetyAlerts
February 27, 2003

Serono Laboratories Has Recalled Gonal-F

 (SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
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 44087-1200-1.
Recall # D-123-3.

CODE
Gonal F lot numbers: BK006A, BK007A, BK008B, BK009A, BK010B, BK012A, BK013A
(Prefilled Syringe Diluent Lot Numbers: 1-BEX-701, 1-BEX-702, and 2-BEX-701).

RECALLING FIRM/MANUFACTURER
Serono Laboratories, Inc, Rockland, MA, by letter dated November 21, 2002. Firm initiated recall ongoing.

REASON
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
92,653 units.

DISTRIBUTION
Nationwide.

 

 
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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.