Vial Defects Detected in Roche's Herceptin in Europe

London (Nov. 22)-The European Medicines Agency (EMEA, www.emea.eu.int) reports a defect in some vials of Herceptin (trastuzumab), the anticancer treatment by Roche (Basel, Switzerland, www.roche.com), which have been distributed in Europe. As a result, The EMEA’s Committee for Medicinal Products for Human Use outlined a plan, formulated in conjunction with Roche, for visually reinspecting and replacing defective vials. The plan seeks is to identify and remove defective vials while maintaining supply of the drug.

Herceptin is packaged in a 15-mL clear glass vial. The defect stems from a fault during the packaging process, which resulted in cracks in the shoulders of the vials in a small percentage of cases, reports EMEA.

“There is a risk that cracked vials may lead to a loss in sterility, which can cause infections in patients. While testing indicates that the cracks have no effect on the sterility of the product, the company has been advised as a precautionary measure to reinspect the vials and replace the cracked vials,” said EMEA in a press release.

Only vials packaged from March 2006 are affected by the defect. Roche has received about 20 complaints of cracked vials from hospitals in France, Germany, Ireland, and the United Kingdom. In most cases, the vials broke when the flip-top cap was removed. In two cases only cracks were reported. Following the reports, the company inspected 13,000 packaged vials, and found that 1 in 1,000 had a cracked bottleneck. Cracked vials may still be in circulation.

Roche has provided every hospital and treatment center using Herceptin with instructions for examining vials for cracks. Roche has further committed to ensure that each hospital reports back its findings and does not use any affected vials found. This only affects batches distributed before November 2006.

The EMEA asked Roche to submit weekly status reports on the progress of the recall activities and the numbers of defective vials identified pending resolution of the situation. Inspections of specific good manufacturing practices also will also conducted.