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Single Lot of Epoetin Alfa Recalled Due to Damaged Vials
BRIDGEWATER, NJ -- August 6, 2008 -- Ortho Biotech is announcing that it is voluntarily recalling 1 manufacturing lot (P114942A) of Epoetin alfa (Procrit) after having identified cracks in the necks of a small number of vials upon postmanufacturing inspection.
No other lot of this product is affected by this recall. Approximately 44,292 vials of lot P114942A in the following packaging configurations were distributed between April 15, 2008, and July 17, 2008:
· NDC 59676-312-00
o Lot P114942A, Expiration Date: 12/10
o Individual multi-dose vials of Epoetin alfa (Procrit) 10,000 U/2mL
· NDC 59676-312-04
o Lot P114942A, Expiration Date: 12/10
o Cartons containing 4 multi-dose vials of Epoetin alfa (Procrit) 10,000 U/2mL
Vials exhibiting even slight cracks may not maintain their sterile condition and should not be used for subcutaneous or intravenous injection.
The recall is being conducted in cooperation with the US Food and Drug Administration.
Epoetin alfa vials from the above recalled lot should be promptly returned by contacting the returned goods service provider at (800) 668-4391.
Healthcare providers and patients with questions about this recall notice can contact the Ortho Biotech Medical Information Department at (888) 227-5624, Monday through Friday, 8:30 AM to 5:00 PM EDT.
SOURCE: Ortho Biotech
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