Hospira Inc. recalls Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, N

Recalled February 13, 2013 · FDA recall D-154-2013 · Hospira

Hazard

Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. · FDA Class I

Units

31,326 vials

Sold at

Nationwide and Puerto Rico.

Description

Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.

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.

Manufacturer(s)

Hospira Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →