The U sustenance and Drug Administ...

The U sustenance and Drug Administration (FDA) is alerting health care providers and patients to the existence of three allotments of counterfeit product labeled as Procrit (epoetin alfa):

* P007645: 40000 units by mL, expiration October 2004

* P004677: 40000 units for mL, expiration February 2004

* P004839: 40000 units by mL, expiration February 2004

This counterfeit Procrit has been rest to be contaminated with bacteria and therefore describes a significant potential hazard to consumer In addition, FDA testing has demonstrated that an counterfeit product contains no active ingredient. Procrit is used to stimulate the production of r house cells in humans to treat bitter anemia.

The FDA stimulates health care professionals and patients to check the packaging and vials before using the production Counterfeit product should be quarantined and not used. The FDA's Center for Biologics Evaluation and Research should be contacted at 800-835-4709 (prompt 1 then quick 5), and Ortho Biotech at 800-325-7504 (prompt 2)

Additional information concerning the counterfeit produce is available on the manufacturer's Web site at www.procrit.com/counterfeit/letter.html.

COPYRIGHT 2003 American Academy of Family Physicians

COPYRIGHT 2003 Gale Group