March 05, 2003
IVAX Pharmaceuticals Has Recalled
The Food and Drug
Administration (FDA) released the following information.
ONXOL injection (paclitaxel), 300 mg/50 mL (6mg/mL), 50 mL Multi Dose
Vial, Rx only. Recall # D-161-3.
M026861 Exp Date 02/04.
IVAX Pharmaceuticals, Miami, FL, by letter on January 20, 2003. Firm
initiated recall ongoing.
Lack of assurance of sterility: Environment in Class 100 Filling room
exceeded the non-viable particulate limit specification.
VOLUME OF PRODUCT IN COMMERCE