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

 

 

No other lot numbers of product are impacted by the incident. The product has tamper-evident features that can be used to authenticate the package. The amount of stolen and withdrawn product represents a very small proportion within the distribution channel; therefore, Centocor does not anticipate a disruption in product availability for patients.

Infliximab is approved for patients with rheumatoid arthritis (RA)?adults with moderate-to-severe active RA, (infliximab taken concurrently with methotrexate); Crohn's disease?children >6 years and adults who have not responded well enough to other medicines; plaque psoriasis?adult patients with chronic severe, extensive, and/or disabling plaque psoriasis; ulcerative colitis?adults with moderate-to-severe active ulcerative colitis who have not responded well enough to other medicines; ankylosing spondylitis; and psoriatic arthritis.