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Disclaimer
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 trastuzumab |
| Herceptin |
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Pharmaceutical
company:
Genentech
www.gene.com |
NEW WARNING
Genentech has issued a "Dear Healthcare Provider" letter to address complaints concerning damaged and broken vials of trastuzumab (Herceptin) 440 mg and BWFI diluents (NDC# 50242-0134-68, List #15534). The affected vials were shipped from mid-2007 to present. Damaged vials may become contaminated, which can cause infection in patients. Genentech believes the risk to patients is low because of the obvious damage to the affected vials. However, they request that health care providers inspect the cartons for any signs of leakage (such as moisture on the carton or the surface of the vials), inspect the vials for cracks or other damage, and observe the vial during reconstitution for signs of vacuum loss in the vial. If a compromised vial is discovered, don't use it, and contact Genentech product support at 1-800-334-0290.
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