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December 28, 1999

Chiron Corp. Recalls DepoCyt™

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 month stability).

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.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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