CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11

Recall Number: D-928-2013

Firm: Teva Pharmaceuticals USA, Inc.

Classification: Class II

Status: Terminated

Report Date: 20130911

Initiation Date: 20130813

Termination Date: 20140827

Reason for Recall

Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.

Product Description

CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11