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There is a risk that damaged vials may lead to a loss in sterility.
Genentech 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, according to Genentech. The company, however, believes the risk to patients is negligible because of a low occurrence rate and the obviousness of the affected vials.
Healthcare professionals should inspect cartons of the product for signs of leakage, cracks, and other damage to the vials; observe the vials during reconstitution; and check for loss of vacuum in the containers.
The company said it has not identified any systemic error in the internal manufacturing process for Herceptin that would cause the damage.
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