Hospira downgraded as it recalls more sterile injectables
pharmafile | December 18, 2012 | News story | Manufacturing and Production |Â Â FDA, HospiraÂ
Generic pharma company Hospira’s efforts to bring its manufacturing network back into compliance took a knock this week when it was forced to undertake yet another recall.
The firm is recalling three lots of its carboplatin injection cancer drug after seeing visible particles – subsequently identified as carboplatin crystals – in a retain sample. The affected lots were distributed Nationwide and in Puerto Rico between March and September 2012.
A Food and Drug Administration advisory notes that if particulate matter from crystallisation is injected into a patient, it may potentially become lodged in and obstruct blood vessels: causing local infarction, thromboembolism and vasculitis.
Hospira has not received reports of any adverse events and has started an investigation into the quality failure.
The pharma company – which has been trying to rectify quality issues at three of its manufacturing plants – has also been downgraded by investment bank Goldman Sachs on the grounds that it will have to invest more money “to shore up quality systems and support future growth”.
Hospira 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, was also affected by compliance issues but passed an FDA inspection last year.
Goldman Sachs downgraded the company from ‘neutral’ to ‘sell’ after concluding that “since the issuance of the Rocky Mount FDA warning letter in 2010 and subsequent FDA observations … the timelines for remediation have been continually elongated and estimates for associated costs have steadily increased”.
Towards the end of 2011 Hospira unveiled a $375 million investment programme designed to get the plants back on track, increasing its earlier cost estimate by $100 million.
Goldman Sachs also said that Hospira was facing a major patent expiration which will depress earnings between now and 2015.
Phil Taylor
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