Showing posts with label Another Hospira recall follows a 22-page FDA 483 Observation Report. Show all posts
Showing posts with label Another Hospira recall follows a 22-page FDA 483 Observation Report. Show all posts

Monday, April 8, 2013

Another Hospira recall follows a 22-page FDA 483 Observation Report



April 8th, 2013 · No Comments · Uncategorized

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. Hospira said 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.
Read the FDA 483 Observation Report. Go to: http://1.usa.gov/10pwzWI
Quoted from here