Drug 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.
D-154-2013
Product summary
- Firm
- Hospira Inc.
- Event
- Event 63548
- Status
- Completed
- Classification
- Class I
- Quantity
- 31,326 vials
- Official record key
drug-enforcement:D-154-2013
Official wording
Reason: Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Code information: lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
particulates