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FDAFDA · Food and drugs·Recall number D-928-2013

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

Published September 11, 2013 · Recall initiated: August 13, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Teva Pharmaceuticals USA, Inc.
Distributor
Nationwide
Lot
Lot 31314458B, 31314459B exp.08/14, 31315794 exp. 10/14, 31315982B exp.11/14
Risk classification
Class II
Area (FDA)
drug
Country
United States

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