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To ensure patient safety, Centocor and Ortho Biotech are voluntarilywithdrawing products with lot numbers matching those of the stolen productfrom the market and communicating this action to all authorized distributorsand all prescribing physicians, healthcare providers, and patients.
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If the stolen product were to be reintroduced into distribution channels,the companies cannot guarantee that products were stored at appropriatetemperatures, nor can the companies guarantee the products were not damaged.A voluntary withdrawal of products with lot numbers corresponding to that ofthe stolen product minimizes the possibility of inadvertent use of stolenproduct by physicians and, therefore, the overall risk to patients.
On May 7, 2008, JOM discontinued shipment of products with lot numbersmatching those of the stolen product. Healthcare providers and patients thatdid receive product shipped from an authorized distributor on or before thisdate should consider the product safe for use. Healthcare providers andpatients that are concerned about products shipped after this date with thefollowing NDC and lot numbers can return the product by contacting thecompanies at (888) 626-5660:
No other lot numbers of product are impacted by this incident. All threeof these products have tamper-evident features that can be used toauthenticate the package. Healthcare professionals and patients who haveconcerns about any product they possess may contact the number below forassistance with the identification of these features.
The amount of stolen and withdrawn product represents a very smallproportion of the total product within the distribution channel; therefore thecompanies do not anticipate a disruption in product availability for patients.
JOM, Centocor, and Ortho Biotech will continue to work closely withhealthcare providers and authorized distribution partners to identify andisolate product with lot numbers corresponding to those of the stolen product,and ask that anyone report any questionable activities to the appropriateauthorities. Healthcare professionals, distributors or patients are asked todirect questions related to this voluntary withdrawal to the companies bycalling (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 dedicatedto providing safe and on-time delivery of pharmaceutical products for OrthoBiotech, L.P., Centocor, Inc., and other U.S. pharmaceutical companies.
About Ortho Biotech, L.P.
Ortho Biotech Products, L.P. is a leading biopharmaceutical companydevoted to helping improve the lives of patients with cancer and with anemiadue to multiple causes, including chronic kidney disease. Since it wasfounded in 1990, Ortho Biotech and its worldwide affiliates have earned aglobal reputation for researching, manufacturing and marketing innovativeproducts that enhance patients' health. Located in Bridgewater, N.J., OrthoBiotech is an established market leader in Epoetin alfa therapy for anemiamanagement.
