Cancer drugs have been recalled for glass particle contamination, the U.S. Food & Drug Administration (FDA) just announced. Hospira, Inc., maker of injectable drugs and infusion technologies, issued the recall following a previously communicated user level recall of 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate. That recall was issued in the United States due to visible particles embedded in the glass located at the neck of the vial.
There may be the potential for the product to come into contact with the embedded particles and the particles may become dislodged into the solution. Should particulate matter become injected into a patient, there may be the potential for patient injury and the need for medical intervention. 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, to date, and has completed an investigation and attributed the root cause to a supplier glass defect. Corrective and preventive actions have been identified and initiated.
The recalled products are packaged in vials and are used to treat various types of cancer. 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 U.S. on June 27, 2012 and is arranging for return and replacement of all recalled products. Formal recall letters were distributed within the U.S. along with notification to safety organizations
Anyone with an existing inventory in the U.S. is advised to stop use and distribution; quarantine the product immediately; and call Stericycle, toll-free, at 1.888.628.0734, between 8:00 a.m. and 5:00 p.m., Eastern Daylight Time (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. Customers can call Hospira Customer Care at 1.877.976.7747, between 8:00 a.m. and 5:00 p.m., Central Daylight Time (CDT), Monday through Friday, to order replacement product. Medical inquiries should be directed to Hospira Medical Communications at 1.800.615.0187, which is available 24 hours a day, seven days a week.
Adverse reactions or quality problems experienced with use of these products may be reported to the FDA’s MedWatch Adverse Events Program 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; or Fax to 1.800.FDA.0178
This recall also impacts several products distributed outside of the United States (see Table 2 at http://www.fda.gov/downloads/Safety/Recalls/UCM311977.pdf. Hospira is working with regulatory authorities outside the U.S. to address the issue in other countries where the products were distributed. In some cases, recalls are taking place. These affected lots were distributed from November 2011 through May 2012.
This year, we wrote that Hospira recalled Hydromorphone Injections that may have contained more than the intended volume and, prior to that, Morphine Injections that may have been over-filled.