Supplier defect blamed in Hospira recall case
pharmafile | July 24, 2012 | News story | Manufacturing and Production | FDA, Hospira, Michael Ball
Hospira has concluded that a supplier defect was the root cause of its recall of four cancer drugs in the US earlier this month because of problems with their glass vials.
The company said on 13 July it was recalling 19 lots of carboplatin, cytarabine, methotrexate and paclitaxel shipped between September 2011 and April 2012 because of visible particles embedded in the glass at the neck of the vials.
Although Hospira says it has not received any reports of adverse effects with the products, it notes that the particles could become dislodged into the solution and be injected into a patient, putting them at risk of injury.
Meanwhile, Health Canada has warned physicians not to use three lots of paclitaxel for similar reasons.
“Hospira has completed an investigation and attributed the root cause to a supplier glass defect,” said the company in a statement, adding that corrective and preventive actions have been identified and initiated.
No shortages are expected as a result of the action because additional lots of the products are available in the supply chain and are unaffected by the problem, said the firm.
Hospira has been plagued by recalls because of manufacturing defects in recent months, and was name-checked along with other companies such as Teva, Sandoz and Bedford Laboratories in a Congressional report looking into the reason for widespread drug shortages in the US last month.
All four companies have been held up by the FDA for quality defects at manufacturing plants, and a recent Reuters report noted that they accounted for 58% of medicines on the FDA’s current shortage list.
Remediation update
Hospira has been working to tackle its manufacturing problems, upgrading facilities in Austin, Texas, Lake Forest, Illinois, and Clayton and Rocky Mount in North Carolina to rectify quality issues.
Hospira chief executive Michael Ball said in May that Rocky Mount is running at 60%-70% capacity and is steadily adding staff as remediation work progresses, with 100 workers added since the start of 2012.
The Clayton facility encountered some additional manufacturing problems in March which required a shutdown, leading to a temporary shortage of the anaesthetic propofol, although production has now restarted.
Additional corrective actions have been taken at the Austin facility in preparation of an FDA inspection, while Lake Forest recently passed an inspection with zero observations, said Ball.
Phil Taylor
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