Recall -- Firm Press Release
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Hospira Issues Voluntary Nationwide Recall of Three Lots of Carboplatin Injection Due to Visible Particulate Matter
FOR IMMEDIATE RELEASE - December 14, 2012 - Lake Forest, Ill - Hospira, Inc. (NYSE: HSP), issued this press release today to further inform 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.
- Online: www.fda.gov/medwatch/report.htm
- Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the FDA.
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com.