FDAFDA · Food and drugs·Recall number D-154-2013
Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia.
Published February 13, 2013 · Recall initiated: November 8, 2012
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CARBOPLATIN
- Manufacturer
- Hospira Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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