FDA -Recall of Some IV Chemo Drugs

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Hospira Announces A Nationwide Recall of Certain Lots of Injectable Carboplatin, Cytarabine, Paclitaxel and Methotrexate Due to Glass Vial Defect

FOR IMMEDIATE RELEASE -July 13, 2012 – Hospira, Inc. (NYSE: HSP), the world’s leading provider of injectable drugs and infusion technologies, issued this press release today to further inform the general public about a previously communicated user level recall of a total of 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate (see table below) in the United States due to visible particles embedded in the glass located at the neck of the vial. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.

Hospira has not received any reports of adverse events related to these lots. Hospira has completed an investigation and attributed the root cause to a supplier glass defect. Corrective and preventive actions have been identified and initiated.

These products are packaged in vials and are used to treat various types of cancer. In addition, methotrexate is also used to treat psoriasis and rheumatoid arthritis. These products were distributed nationwide to wholesalers and direct customers. Hospira issued a recall letter in the United States on June 27, 2012.

Hospira is arranging for return/replacement etc. of all recalled products. Formal recall letters have been distributed within the US along with notification to safety organizations

Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately and call Stericycle at 1-888-628-0734, between the hours of 8am to 5pm EDT, Monday through Friday, to arrange for the return of the product. For U.S. customers, replacement product from other lots is available and no drug shortages are expected as a result of this recall. Customers can call Hospira Customer Care at 1-877-976-7747, between the hours of 8am to 5pm CDT, Monday through Friday, to order replacement product.

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 these products may be reported to the FDA’s MedWatch Adverse Events Program either online, by regular mail or by fax.

   Online:  http://www.fda.gov/medwatch/report.htm
   Regular mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm
   Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

This issue also impacts several products distributed outside of the United States, as shown in Table 2. Hospira is working with regulatory authorities outside of the United States to address the issue in other countries where the products were distributed, and in some cases, recalls are taking place. These affected lots were distributed from November 2011 through May 2012.

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