Drug recall D-154-2013
Product
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.
Reason for recall
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Lots and codes
lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 31,326 vials
- Distribution
- Nationwide and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 8, 2012
- Terminated
- March 20, 2017
Related products
- Carboplatin – drug information
- NDC 61703-360 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.
- NDC 61703-339 Carboplatin · Carboplatin 10 mg/mL · Hospira, Inc.