Ortho Biotech is voluntarily recalling one manufacturing lot (P114942A) of PROCRIT(R) (Epoetin alfa) after having identified cracks in the necks of a small number of vials upon post-manufacturing inspection. No other lot of this product is affected by this recall. Approximately 44,292 vials of lot P114942A were distributed between April 15, 2008 and July 17, 2008. Vials exhibiting even slight cracks may not maintain their sterile condition and should not be used for subcutaneous or intravenous injection.To ensure patient safety, Ortho Biotech is voluntarily recalling PROCRIT vials from this manufacturing lot only. Ortho Biotech is notifying the authorized distributors, prescribing physicians and patients of this recall. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. PROCRIT from manufacturing lots other than the above, shipped from an authorized distributor is not being recalled. The amount of PROCRIT being withdrawn represents a very small proportion of the total product within the distribution channel; therefore the company does not anticipate a disruption in product availability for patients.
