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More than 44,000 Vials of Procrit Recalled

Aug 6, 2008 | Parker Waichman Alonso LLP

Procrit is being recalled by Johnson & Johnson subsidiary Ortho Biotech.  According to the company's recall notice, the action is necessary because cracks in the necks of a small number of Procrit vials were discovered upon post-manufacturing inspection.

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

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.

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. When Procrit was first approved in 1989, the drug was touted as a treatment to lessen fatigue and improve quality of life among cancer and HIV patients with anemia. But since then, Procrit has been forced to undergo several label changes, and the label now states that there was no evidence to back that claim.

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 modified to say that the 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.

The FDA ordered the labeling changes because several studies have shown that Procrit and other ESAs increased tumor growth and shortened survival time in some cancer patients.