July 16, 2012 — The injectable drug company Hospira, Inc. has announced a voluntary recall of four cancer drugs. Due to a manufacturing defect in the vial, glass particles could become dislodged and be injected into a patient.
The company is recalling 19 lots of the following drugs: carboplatin cytarabine, paclitaxel, and methotrexate. The company says that they do not expect a drug shortage in the U.S. because the vial manufacturer has already fixed the problem, customers have been notified, and replacements have been sent in many cases.
The recalled drugs are used primarily in the treatment of various cancers. Methotrexate is also prescribed to treat diseases such as rheumatoid arthritis and psoriasis. The affected drugs were sold from September 2011 until April 2012. On June 27, 2012, Hospira sent notifications to wholesale retailers, individual buyers, and clinic that purchased the drugs. The drugs were also sold internationally, and Hospira is currently in the process of recalling the drugs globally.
An investigation from Hospira revealed a defect in the design of the vial, with glass particles embedded in the neck. If the particles became dislodged and were accidentally injected into a patient, they could cause serious injury. The company warned at symptoms of injury could include bleeding, bruising, inflammation, itching, rash, chest pain, and respiratory distress. Fortunately, Hospira has not received any reports of injury due to the defect.
Hospira is recommending that physicians monitor patients who may have received a defective drug. Any remaining product should be quarantined and returned to the company. Customers who contact Hospira can order replacement products. Finally, any injuries should be reported to the FDA via the MedWatch Adverse Event surveillance program. This program can be accessed online at http://www.fda.gov/medwatch/report.htm