NEW BRUNSWICK, N.J. Johnson & Johnson’s subsidiary Ortho Biotech is recalling more than 44,000 vials of the erythropoiesis-stimulating agent Procrit because its post-manufacturing inspection found cracks in a small number of vials.
Only one lot is being recalled. It was distributed by J&J’s JOM Pharmaceutical Services warehouse between April 15 and July 17.
Other Procrit lots distributed by JOM are not affected by the recall, which is being conducted in cooperation with the FDA, the company said. The amount being recalled is a small portion of the Procrit in distribution, and no supply disruptions are anticipated.
“Vials exhibiting even slight cracks may not maintain their sterile condition and should not be for subcutaneous or [IV] injection,” Ortho Biotech said.