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Cytarabine for Injection Recalled for Potential Sterility Issues

Filed February 24th, 2012 Julie

Bedford Laboratories has announced a voluntary recall of three lots of Cytarabine for Injection, USP:

Cytarabine for injection, USP 1 gram per viral – NDC #55390-133-01

• Lot 2066986 – Exp. Date March 31, 2014
• Lot 2111675 – Exp. Date April, 30, 2014
• Lot 2131148 – Exp. Date May, 31, 2014

Bedford issued the recall because a post-release investigation of the manufacturing area revealed the specified lots could not be guaranteed sterile.

Cytarabine is used alongside other anticancer drugs to reduce cancerous cells with a goal of putting patients into remission. It is also used to treat acute lymphocytic luekemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of cytarabine is indicated in the prophylaxis and treatment of meningeal luekemia.

The initial recall notification was shipped by overnight courier and the products were arranged to be returned. Hospitals, emergency rooms, clinics, physician offices and other healthcare facilities and providers are instructed not to use the lots listed above, and should immediately quarantine them. Wholesalers, distributors, and retailers still in possession of the Cytarabine should contact Bedford Laboratories Client Services at 800-562-4797.

Patients, medical facilities, and medical personnel with questions may contact Client Services Department at 800-562-4797 between 8 am and 5 pm, EST, Monday – Friday. Any adverse reactions experienced with any of the lots reported in this release should be also reported to 800-521-5169.

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