Product: CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
Reason for recall: Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
Recall initiated: 20130813
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated