July 16, 2012 — Hospira, Inc. has initiated a recall of four injectable cancer drugs due to the risk that glass particles could be injected into a patient. The four drugs being recalled are: carboplatin cytarabine, paclitaxel, and methotrexate. The company says they do not expect a shortage of the medicines because the problem has been fixed by the company’s glass vial manufacturer, and replacement drugs have been sent.
The four drugs are used to treat various types of cancer. Methotrexate is also used to treat psoriasis and rheumatoid arthritis. The recall involved 19 lots of medicine that were distributed between September 2011 through April 2012. Wholesalers and medical facilities that purchased the drugs were notified of the recall on June 27, 2012. The company is currently in the process of recalling the drugs internationally.
An investigation from Hospira found that the problem was due to visible glass particles embedded in the neck of the vial. During use, it is possible that the particles could become dislodged in the liquid medicine and then be injected into a patient.
Hospira officials said that there were no reports of injury. However, the FDA is warning that signs and symptoms of injury might include bleeding, bruising, inflammation, itching, rash, chest pain, and respiratory distress.
The company is recommending that anyone with existing inventory should stop using and/or distributing the product, quarantine it, and arrange for the product to be returned. Customers can order a replacement of the recalled product. Furthermore, any adverse events should be reported to the FDA’s MedWatch Adverse Events Program, which can be found online at http://www.fda.gov/medwatch/report.htm.
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