March 15, 2000U.S. BioScience, Inc. Recalls
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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