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www.fdanews.com/articles/148069-supplier-glass-vial-defects-prompt-warning-on-hospira-cancer-drug

Supplier Glass Vial Defects Prompt Warning on Hospira Cancer Drug

July 20, 2012

Hospira is looking into a supplier glass defect following consumer complaints and a Health Canada warning to physicians not to use three lots of its cancer treatment paclitaxel injection, 300 mg/50 mL.

Complaints to the company from outside Canada described particles embedded in the glass vial, rust-like marks on the vial and particles in the solution, the agency said. Hospira to date has not received any adverse event complaints for the lots.

“Preliminary root cause findings attribute this issue to a supplier glass defect,” Hospira spokesman Dan Rosenberg said. The company is working with customers and the agency to resolve the issue and take preventive actions, he added. Hospira has also agreed not to release further inventory from the three lots but a shortage situation is not anticipated, Health Canada said.

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