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U.S. Department of Health and Human Services

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Procrit (epoetin alfa) Mar 2003

Audience: Pharmacists and Oncological healthcare professionals

FDA and Ortho Biotech Products alerted healthcare providers and consumers about the existence of three lots of counterfeit product labeled as Procrit (epoetin alfa):

P007645 - 40,000 units/mL, Expiration 10-2004
P004677 - 40,000 units/mL, Expiration 02-2004
P004839 - 40,000 units/mL, Expiration 02-2004

The counterfeit Procrit has been found to be contaminated with bacteria and therefore represents a significant potential hazard to consumers. FDA testing has demonstrated that some counterfeit product contains no active ingredient.

[March 11, 2003 - Press Release - FDA]
[March 8, 2003 - Letter - Ortho Biotech]

Past MedWatch alerts:

[June 6, 2002 Letter - Ortho Biotech] PDF Format
[June 7, 2002 Update - Ortho Biotech] PDF Format
[October 22, 2002 Update - Ortho Biotech]