Hospira, Inc. is further informing the general public about a previously released user level recall of a total of 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate in the United States. The recall is due to visible particles embedded in the glass at the neck of the vial.
Potential may exist 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 is injected into a patient, signs and symptoms may include bleeding, bruising, inflammation, itching, rash, chest pain, and respiratory symptoms. However, Hospira has not received any reports of adverse events related to these lots.
These products were distributed nationwide to wholesalers and direct customers. Hospira is arranging for return or replacement of all recalled products.
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 8 am and 5 pm EDT, Monday through Friday, to arrange for the return of the product.
For US 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 8 am and 5 pm CDT, Monday through Friday, to order replacement product.
For medical inquiries, please contact Hospira Medical Communications 24 hours a day, 7 days a week at 1-800-615-0187.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Events Program,
www.fda.gov/medwatch/report.htm.
This recall is being conducted with the knowledge of the FDA.
Source: FDA.