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March 15, 2000

U.S. BioScience, Inc. Recalls NeutrexinÆ Injection

West Conshohocken, PA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that U.S. BioScience, Inc. is recalling NeutrexinÆ Injection because of lyophilized cake discoloration (white to tan).

The recalled NeutrexinÆ Injection (Trimetrexate glucuronate for injection), 25mg, in single vial, 10 pack vials and 50 pack vials, is a prescription indicated for use with concurrent leucovorin administration, as an alternative therapy for the treatment of moderate to severe Pneumocystis carinii pneumonia (PCP) in immunocompromised patients, including patients with AIDS, who are intolerant of, or are refractory to, trimethoprim-sulfamethoxazole therapy.  The product was manufactured by Ben Venue Laboratories of Bedford, Ohio.

Over 20,000 vials (Single vial NDC #58178-020-01, 1-pack NDC #58178-020-10, and 50-pack NDC #58178-020-50) were distributed nationwide and and bear the Lot #1020G EXP 12/00.  The firm estimated that less than 1,000 vials remained on market at time of recall initiation.

This ongoing Class III recall was initiated by U.S. BioScience, Inc. by letter dated February 8, 2000. This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #d-234-0

Notice of this product warning was sent via email to SafeMail subscribers March 15, 2000.

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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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