February 27, 2013 | By Eric Palmer
Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
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Sterile injectables maker Hospira ($HSP) is having to recall lots of 5 different products even as FDA inspectors are in one of its plants conducting what the company hopes will be a final inspection that will return the drugmaker to the agency's good graces.
Over the last several days, Hospira recalled three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples. It is recalling one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops.
The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
Read more: Hospira issues 3 recalls as it faces crucial FDA inspection - FiercePharma http://www.fiercepharma.com/story/hospira-issues-3-recalls-it-faces-crucial-fda-inspection/2013-02-27#ixzz2MAnwvSbt
Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma
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