Ortho Biotech Announces Nationwide Voluntary Recall of Procrit(R) (Epoetin Alfa)...

Ortho Biotech Announces Nationwide Voluntary Recall of Procrit(R) (Epoetin
Alfa) Lot Number P114942A

BRIDGEWATER, N.J., Aug. 5 /PRNewswire/ -- Ortho Biotech is announcing that
it 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 in the
following packaging configurations were distributed between April 15, 2008 and
July 17, 2008.

NDC Description Lot Expiration
Number Date
59676-312-00 Individual multi-dose vials
of PROCRIT(R) (Epoetin alfa) P114942A 12/10
10,000 U/2mL
59676-312-04 Cartons containing 4
multi-dose vials of PROCRIT(R) P114942A 12/10
(Epoetin alfa) 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.
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.
PROCRIT 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.
The amount of PROCRIT being withdrawn represents a very small proportion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.
About Ortho Biotech, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical company
devoted to helping improve the lives of patients with cancer and with anemia
due to multiple causes, including chronic kidney disease. Since it was
founded in 1990, Ortho Biotech and its worldwide affiliates have earned a
global reputation for researching, manufacturing and marketing innovative
products that enhance patients' health. Located in Bridgewater, N.J., Ortho
Biotech is an established market leader in Epoetin alfa therapy for anemia
management. The company also markets treatments for recurrent ovarian cancer,
rejection of transplanted organs and other serious illnesses. For more
information, visit www.orthobiotech.com.
SOURCE Ortho Biotech, L.P.

Kassy McGourty, cell +1-908-377-5873, KMcGourt@obius.jnj.com, for Ortho
Biotech, L.P.