Reported Sep 11, 2013 · Terminated
CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC…
Teva Pharmaceuticals USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512
Is this the product you have?
- CARBOplatin Injection, 600 mg/60ml, MultiDose, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618 NDC 0703-3249-11
- Lot codes and dates
Lot 31314458B31314459B exp.08/1431315794 exp. 10/1431315982B exp.11/14
- Amount recalled
- 780 vials
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer.
This product could cause temporary or reversible health problems — stop using it.
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