PlainRecalls
FDA Drug Critical Class I Completed

Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.

Reported: February 13, 2013 Initiated: November 8, 2012 #D-153-2013

Product Description

Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.

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.

Details

Recalling Firm
Hospira Inc.
Units Affected
23,315 vials
Distribution
Nationwide and Puerto Rico.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.. Recalled by Hospira Inc.. Units affected: 23,315 vials.
Why was this product recalled?
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 13, 2013. Severity: Critical. Recall number: D-153-2013.