Crohn's Disease Drugs Stolen - Procrit and Remicade

HORSHAM, Pa., May 15 /PRNewswire/ -- JOM Pharmaceutical Services, Inc. (JOM), a service coordinator that provides delivery services and customer support to Centocor, Inc. and Ortho Biotech, L.P., was notified May 6, 2008, that a transport trailer carrying DOXIL(R) (doxorubicin HCl liposome injection), PROCRIT(R) (epoetin alfa) and REMICADE(R) (infliximab) was stolen while the driver was traveling from a distribution center in Kentucky to a specialty distributor. This incident has been reported to local and federal law enforcement offices, as well as the U.S. Food and Drug Administration; however, the transport trailer and product have not yet been recovered.

To ensure patient safety, Centocor and Ortho Biotech are voluntarily withdrawing products with lot numbers matching those of the stolen product from the market and communicating this action to all authorized distributors and all prescribing physicians, healthcare providers, and patients.

If the stolen product were to be reintroduced into distribution channels, the companies cannot guarantee that products were stored at appropriate temperatures, nor can the companies guarantee the products were not damaged. A voluntary withdrawal of products with lot numbers corresponding to that of the stolen product minimizes the possibility of inadvertent use of stolen product by physicians and, therefore, the overall risk to patients.

On May 7, 2008, JOM discontinued shipment of products with lot numbers matching those of the stolen product. Healthcare providers and patients that did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients that are concerned about products shipped after this date with the following NDC and lot numbers can return the product by contacting the companies at (888) 626-5660:NDC Description Lot Number Expiration
Date
59676-3100-1 Cartons containing six (6)D091534 07/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
10,000 U/mL
59676-3200-4 Cartons containing four (4) P113612 09/2010
multidose vials of
PROCRIT(R) (epoetin alfa)
20,000 U/mL
59676-3400-1 Cartons containing four (4) P106803 06/2010
single dose vials of
PROCRIT(R) (epoetin alfa)
40,000 U/mL
17314-9600-1 Cartons containing 1 0717124 03/2009
DOXIL(R) (doxorubicin HCl
liposome injection) 20mg in
10mL (2 mg/mL) single use vial.
17314-9600-2 DOXIL(R) (doxorubicin HCl 0715423 02/2009
liposome injection) 50mg in
25mL (2mg/mL) single use vial
57894-0300-1 Cartons containing one (1)8AM26021P1 01/2011
vial of REMICADE(R)
(infliximab) 100mg
57894-0300-1 Cartons containing one (1)8BK35014P1 02/2011
vial of REMICADE(R)
(infliximab) 100mg

No other lot numbers of product are impacted by this incident. All three of these products have tamper-evident features that can be used to authenticate the package. Healthcare professionals and patients who have concerns about any product they possess may contact the number below for assistance with the identification of these features.

The amount of stolen and withdrawn product represents a very small proportion of the total product within the distribution channel; therefore the companies do not anticipate a disruption in product availability for patients.

JOM, Centocor, and Ortho Biotech will continue to work closely with healthcare providers and authorized distribution partners to identify and isolate product with lot numbers corresponding to those of the stolen product, and ask that anyone report any questionable activities to the appropriate authorities. Healthcare professionals, distributors or patients are asked to direct questions related to this voluntary withdrawal to the companies by calling (888) 626-5660.
Please see Important Safety Information for REMICADE(R) (infliximab), PROCRIT(R) (epoetin alfa), and DOXIL(R) (doxorubicin HCl liposome injection) at their respective websites.
About JOM Pharmaceutical Services, Inc.

JOM Pharmaceutical Services, Inc. is a service provider that is dedicated to providing safe and on-time delivery of pharmaceutical products for Ortho Biotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.

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.

About Centocor, Inc.
Centocor is harnessing the power of world-leading research and biomanufacturing to deliver innovative biomedicines that transform patients' lives. Centocor has already brought innovation to the treatment of Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.