Hospira has issued another recall, at least its fourth this year, as it continues to struggle to meet FDA expectations at its key sterile injectables plant. The plant has been an ongoing source of disappointment for the company, even as problems there and at other plants have been a gift to competitors who are boosting sales of products that Hospira has had trouble getting to market.
Hospira ($HSP) said in an FDA MedWatch that copper particles were found in a 1000-mL flexible container of its 0.9% sodium chloride injection, a product used as a source of water and electrolytes. Tests found that the particles contained copper, zinc and lead. Hospira warned that the particles might clog small blood vessels or potentially cause copper toxicity. It said it is looking for the root cause of the copper contamination.
The company asked providers to quarantine any of a specific lot of the sodium chloride, which was distributed to pharmacies and distributors between January and March. That would have been during the time that FDA inspectors were crawling over Hospira's Rocky Mount, NC, plant during a re-inspection that the company had hoped would demonstrate it was making sufficient progress to further ramp up production. Instead, inspectors left behind a 21-page Form 483, detailing 20 places where manufacturing continued to fall short.
Read more: Hospira recalls sodium chloride after copper particles found - FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-recalls-sodium-chloride-after-copper-particles-found/2013-04-01#ixzz2PLEEBBcX
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