Erbitux Cracked Vial Leads to Recall

May 1, 2009
A report from a physician’s office of a leaking cap from a vial of cancer treatment Erbitux has prompted a recall of 13 lots with more than 224,000 vials of the biologic.

ImClone, which is now part of Eli Lilly, and Bristol-Myers Squibb (BMS) are partners for the cancer medicine.

“We completed an exhaustive investigation, which included the vial vendor manufacturer, to determine the extent of the potential defect,” BMS said. The vial leaked from undetected split finish cracks, according to the FDA.
Drug GMP Report