Hospira hit by yet another product recall
pharmafile | August 20, 2012 | News story | Manufacturing and Production, Sales and Marketing | Carpuject, Hospira, overdose, recall
Generic pharma company Hospira has been forced to recall another product as it works to rectify quality issues at three of its manufacturing plants.
In the latest action, the specialist in injectable drugs recalled one lot of its Carpuject (hydromorphone) opioid painkiller brand after finding a pre-filled cartridge that that was overfilled, raising the risk of dosing too much of the drug to patients.
Hospira had already warned that some cartridges of Carpuject may be overfilled in May, but at the time decided not to issue a recall because it was concerned that it could lead to shortages of the drug and pharmacists or doctors should be able to spot any affected product.
The earlier notice indicated that some of the cartridges contained twice the regular fill volume, which could lead to life-threatening consequences if delivered to a patient. A recall of one Carpuject lot was carried out in June.
Overdose of opioids can lead to respiratory depression, low blood pressure and reduced heart rate which in some cases can cause circulatory collapse, said Hospira’s latest recall notice.
The company stressed it has not received an reports of adverse reactions as a result of exposure to overfilled Carpuject, adding it has put in place measures to make sure the problem cannot recur.
M&P issues continue to dog firm
Hospira’s manufacturing issues have dominated the company’s operations in recent quarters, and chief executive Michael Ball said on the firm’s second-quarter results call that the FDA had carried out several inspections at its plants and headquarters since the start of the year.
The company has a number of plants under scrutiny by regulators – most notably Rocky Mount and Clayton in North Carolina and Austin in Texas – and brought in external consultants last year to help with remediation efforts.
Another facility in Lake Forest, Illinois – which is the firm’s HQ – was also affected by compliance issues, but passed an FDA inspection last year.
Towards the end of 2011 Hospira unveiled a $375 million investment programme designed to get the plants back on track, upping it earlier cost estimate by $100 million.
Ball told investors last month that Rocky Mount had undergone a planned maintenance shutdown and has since been restored to operation status, running at 60%-70% capacity with a return to slightly higher capacity usage expected later in the year thanks to upgrades and modernisation programmes.
Remediation of the Clayton plant is also going well, he added, with a recent inspection finding only a few non-critical observations and no repeat of the major violations, which were uncovered earlier.
The Austin plant has just been re-inspected and the company is awaiting the FDA’s verdict, while Hospira’s medical device manufacturing facility in Lake Forest has also been issued with a Form 483 for various violations.
“I am committed to resolving our quality issue and getting as much done in 2012 as possible”, said Ball, while cautioning: “It is not a quick fix. It is complex [and] it takes time and money”.
Phil Taylor
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