December 28, 1999Chiron Corp.
Emeryville, CA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Chiron Corporation is recalling DepoCyt,
made by SkyePharm, Inc. because the product failed % free cytarabine specification (6
This ongoing Class III recall was initiated
by the company by letter fax and telephone beginning October 5, 1999. This is the
first public notice issued by the FDA.
The Recalled DepoCyt
(Cytarabine liposome injection), 50 mg/mL (10 mg/mL), in 5 mL sterile, single use vial, is
a prescription cytotoxic anticancer drug. NDC #53905-331-01. The recalled lot numbers are
99-0004 and 99-0004A. Over 560 vials were distributed Nationwide.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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