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news.Hospira has recalled 9 lots of cancer drugs including carboplatin, cytarabine, paclitaxel, and methotrexate packaged in vials in the US.
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The recall, which is based on the appearance of visible particles embedded in the glass located at the neck of the vial, is being conducted with the knowledge of the US Food and Drug Administration (FDA).
The FDA said the products may have the potential to come into contact with the embedded particles and the particles may become dislodged into the solution, which may lead to bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.
Hospira has completed an investigation, identification and attributed the root cause to a supplier glass defect, and started corrective and preventive actions.
Hospira said the issue also impacts several products distributed outside of the US, thus it is working with regulatory authorities outside of the US to address the issue in other countries where the products were distributed between November 2011 and May 2012.