BMS and ImClone Recall Erbitux

ImClone Systems, Inc. (Branchburg, NJ), and Bristol-Myers Squibb (BMS, New York, NY) voluntarily recalled 13 lots of their cancer drug Erbitux (cetuximab) after a report from a doctor’s office about a leaking cap on a vial of the biologic.

The recall was initiated on March 5 and published in the FDA’s enforcement report on March 25. According to the report, the crack could compromise the sterility of the product.

The root cause was a split finish created during the forming of the vial, said Sarah Koenig, associate director of business communications at Bristol-Meyers Squibb (BMS). “The companies completed an exhaustive investigation, which included the vial vendor manufacturer (Hollister-Stier Laboratories), to determine the extent of the potential defect,” she added.

“We identified the issue leading to the recall and promptly moved ahead to determine the scope and necessary corrective actions,” said Koenig. The number of vials involved in this recall represents a very small percentage of the number of Erbitux vials sold annually. “This recall has not resulted in any interruption or shortage of supply of Erbitux,” she said.

Erbitux is approved for treating advanced colorectal cancer and head and neck cancers. BMS and ImClone, which is now part of Eli Lilly, are partners on the cancer drug.

The lot numbers that have been recalled can be found in the FDA’s enforcement report:http://www.fda.gov/bbs/topics/ENFORCE/2009/ENF01100.html>