Global recall includes hematology drugs

A US pharmaceutical company has announced a global recall of 45 lots of drugs, including several anticancer agents, an anticoagulant, and an iron chelator.

The company, Hospira, Inc., issued the recall after discovering particles embedded in the glass at the neck of drug vials.

The recall is precautionary, as exposure to these particles could result in injury, but no adverse events have been reported to date.

Within the US, the recall affects lots of cytarabine, methotrexate, carboplatin, and paclitaxel.

The recall also includes lots of heparin, desferrioxame, oxaliplatin, fluorouracil, epirubicin, carboplatin, paclitaxel, and methotrexate distributed in Europe, Asia, Canada, Australia, and New Zealand.

For a detailed list of the affected drugs, including their batch numbers and expiration dates, visit http://www.fda.gov/downloads/Safety/Recalls/UCM311977.pdf.

Though Hospira has not received reports of adverse events related to these drugs, the company said there is a risk that the particles embedded in the vials might become dislodged.

And if this particulate matter is injected into patients, injury could result. Signs and symptoms of injury might include bleeding, bruising, inflammation, itching, rash, chest pain, and respiratory symptoms.

Hospira has said it is arranging for the return and replacement of all recalled products. US customers can arrange to return products by calling Stericycle at 1-888-628-0734. To order replacement products, customers can call Hospira Customer Care at 1-877-976-7747.

The company said it is also working with regulatory agencies outside the US to address the recall in the countries where the affected drugs were distributed.

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