Centocor, Inc (HORSHAM, Pennsylvannia) reported that JOM Pharmaceutical Services, Inc, a service coordinator that provides delivery services and customer support to Centocor, was notified May 6, 2008, that a transport trailer carrying infliximab (Remicade®) was stolen en route to a specialty distributor. The incident was reported to local and federal law enforcement offices, as well as to the US FDA; however, the transport trailer and product have not yet been recovered. If the stolen product were to be reintroduced into distribution channels, Centocor cannot guarantee that it was stored at appropriate temperatures or was not damaged.
To ensure patient safety, Centocor is voluntarily withdrawing from the market products with lot numbers matching the stolen product and communicating this action to all authorized distributors, to prescribing physicians and healthcare providers, as well as to patients. A voluntary withdrawal of product with lot numbers corresponding to that which was stolen 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 product with lot numbers matching the stolen product. Healthcare providers and patients who did receive product shipped from an authorized distributor on or before this date should consider the product safe for use. Healthcare providers and patients who are concerned about product shipped after this date with the following NDC and lot numbers can return it by contacting the company at (888) 626-5660:
NDC Description Lot Number Expiration Date
57894-0300-1 Cartons containing one (1) vial of infliximab (Remicade)
100 mg 8AM26021P1 01/2011
57894-0300-1 Cartons containing one (1) vial of infliximab (Remicade)
100mg 8BK35014P1 02/2011
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