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Procit Recalled Due to Damaged Vials

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Ortho Biotech is recalling more than 44,000 vials of  Procrit after cracks were found in some vials.

Procrit is an erythropoiesis-stimulating agent (ESA). ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. Other ESAs include Aranesp and Epogen. All are made by Amgen, but Procrit is sold by Ortho Biotech under a licensing agreement.

Earlier this month, the Food & Drug Administration (FDA) mandated that the labeling of Procrit and other ESAs be modifiedafter several studies have shown that Procrit and other ESAs increased tumor growth and shortened survival time in some cancer patients.

The new labeling will say that drugs shouldn’t be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated. The FDA also ordered inclusion of a statement that the drugs aren’t to be administered when hemoglobin levels are greater than or equal to 10 grams per deciliter. Language is being removed that seemed to imply that it was safe to continue treating patients until their hemoglobin rose to 12 grams per deciliter.

According to the recall notice, Procrit vials exhibiting even slight cracks may not maintain their sterile condition and should not be used for subcutaneous or intravenous injection. Procrit vials from the recalled lot should be promptly returned by contacting the returned goods service provider, at (800) 668-4391.

The Procrit recall involves approximately 44,292 vials of lot P114942A distributed between April 15, 2008 and July 17, 2008. The recalled Procrit vials were available in the following packaging configurations:

  • Individual multi-dose vials 10,000 U/2mL; NDC #59676-312-00; Expiration date 12/10
  • Cartons containing 4 multi-dose vials 10,000 U/2mL; NDC 59676-312-04; Expiration date 12/10
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