Sterile injectable drug maker Hospira ($HSP) last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.
In a release, the drugmaker said that it was recalling propofol injectable emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level. It reported that the glass vial contained visible embedded metal particles. It said that upon further analysis, it also discovered free-floating metal particles in vials. The company has taken steps in its manufacturing process so the problem won't recur and said it has not had any reports of adverse effects.
In a separate notice, Hospira recalled a single lot of preservative-free 1% lidocaine HCI injection, USP, 10mg/mL, 30-mL single dose after a customer complained of orange and black particles both in the solution and embedded in the glass vial. Hospira said that turned out to be iron oxide.
Propofol landed on the FDA drug shortage list several years ago when both Hospira and Teva Pharmaceutical Industries ($TEVA) quit producing the anesthetic because of manufacturing problems. Ball made a point to analysts during an earnings call in November 2012 to say that its plant in Clayton, NC, was again producing the drug and that it expected to ramp up production through 2013. During that time, however, it had to recall three lots of the drug because particulate matter was found in retained samples. Teva returned to the market with its propofol product in March 2013. It is not currently on the FDA shortage list.
Manufacturing http://www.fiercepharmamanufacturing.com/story/hospira-recalls-7-lots-propofol-and-one-lidocaine/2014-04-21#ixzz2zdC6RGKY
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