Health Canada has issued a warning about vials of Hospira's ($HSP) paclitaxel, which is used in chemotherapy, after complaints from other countries that some of them contain particles either embedded or floating in the mitotic inhibitor solution.
Because of the potential the particles could cause an embolism, the health agency is recommending that providers use an in-line filter to protect patients from the contaminant. Hospira has not received any reports of adverse reactions, reports in-Pharma Technologist.
The sterile injectable manufacturer has been deep into remediation efforts at three of its plants after problems were noted last year by the FDA. But difficulties have persisted. In April and May, the company alerted the FDA that it had released overfilled cartridges, including some containing morphine and hydromorphine. The FDA decided that a recall might cause a shortage of the drugs and so instead it and Hospira alerted healthcare providers they needed to visually inspect the cartridges and then make sure patients received the appropriate dose.
The company has been making improvements to plants in Austin, TX, and Clayton and Rocky Mount, NC. The Rocky Mount plant closed in December for maintenance then resumed production in January after throwing extensive resources at fixing problems. In its last earnings report, Hospira said a 4% decline in net sales to $966 million could be attributed, in part, to the "adverse impact to supply of the company's quality-improvement and remediation initiatives."
- read the in-Pharma Technologist story
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Hospira earnings decline tied to ongoing remediation