Hospira Recalls of Three Lots of Carboplatin Injection Due to Visible Particulate Matter

This recall is being posted in the event that veterinarians use this chemotherapy drug in treating their patients.

Product Returns: (877) 650-8362

Hospira, Inc. is further informing the general public about a previously communicated voluntary user-level recall of three lots of Carboplatin Injection due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira customers were notified of the issue in early November 2012.

In the event where particulate matter is injected into a patient, there may be the potential for serious and/or life threatening patient injury. In general, if particulate matter from crystallization is injected, it may potentially become lodged in and obstruct blood vessels, potentially causing local infarction, thromboembolism and vasculitis. Chronically, following sequestration, granulomatous formation in the lungs is possible. 

Carboplatin Injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. Carboplatin Injection is indicated for the palliative treatment of patients with ovarian carcinoma recurrent after prior chemotherapy, including patients who have been previously treated with Cisplatin.

The impacted product is identified below:

Product NDC Number Lot Expiration Date
Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial 61703-339-50 Z011711AA AUG2013
Carboplatin Injection, 600 mg/60 mL, 10 mg/mL, Cytotoxic Agent, 60 mL Multi Dose Vial 61703-339-56 Z021650AA AUG2013
Carboplatin Injection, 450 mg/45 mL, 10 mg/mL, Cytotoxic Agent, 45 mL Multi Dose Vial, NOVAPLUS™ 61703-360-50 Z011711AB AUG2013

The affected lots were distributed Nationwide and in Puerto Rico between the dates of March 2012 and September 2012.

Hospira has not received reports of any adverse events or product quality complaints known to be associated with the issue for these lots. This recall is being conducted as a precautionary measure.

Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-877-650-8362 between the hours of 8am and 5pm EST, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available.

For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

Published: December 17, 2012;    Updated: December 17, 2012

Filed Under: Recalls Warnings

Source: FDA

)