Hospira, Inc. is informing health care professionals about a previously communicated user level recall of a total of 19 lots of carboplatin, cytarabine, paclitaxel, and methotrexate 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, which are listed in the Hospira press release. Hospira has completed an investigation and attributed the root cause to a supplier glass defect. Corrective and preventive actions have been identified and initiated.
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