Broken Vials of Herceptin May Lead to Loss in Sterility

Genentech (South San Francisco, CA) has informed healthcare professionals that an increased number of complaints have been received regarding damaged and broken vials of Herceptin 440 mg and BWFI (bacteriostatic water for injection) diluent. The affected vials are NDC# 50242-0134-68, List # 15534. There is a risk that damaged vials may lead to a loss in sterility, which can cause infections in patients.

A survey of the company’s adverse event surveillance systems did not indicate evidence of a change in the safety profile of Herceptin as a result of this vial damage. Genentech believes the risk to patients is negligible because of a low occurrence rate and the obviousness of the affected vials.

Genentech has not identified any systemic error in the internal manufacturing process for Herceptin that would cause this vial damage but the company has requested healthcare professionals to inspect cartons of the product for signs of leakage, cracks, and other damage to the vials.

Genentech’s letter (PDF)