In a nod to the contaminated injectable medicines that caused the U.S. fungal meningitis outbreak in the fall of 2012, two compounding pharmacies have exercised "extra caution" in recalling some potentially suspect medications, according to abcnews.go.com. The U.S. Food and Drug Administration has issued recall alerts to health facilities and physicians who may have received shipments of any of the recalled drugs.
MedPrep Consulting Voluntarily Recalls Products Nationwide
MedPrep Consulting, Tinton Falls, N.J., issued a recall of all its products, 83 in total, nationwide to healthcare facilities and physicians who may have received shipments of the compounded medications on March 17, followed by an FDA-issued recall notice the same day.
MedPrep Consulting's recall notice stemmed from notification from a Connecticut hospital that it had noted visibly evident particulates in 50 cc bags of magnesium sulfate 2gm in dextrose 5% in water, a solution intended to be given intravenously. The particulate has been identified as mold and has been found in a total of five bags of the solution.
Distribution of the recalled products occurred through March 13, 2013. Compounded solutions in plastic syringes were distributed throughout the United States to physician offices and clinics; compounded solutions in all other types of containers were distributed regionally to hospital pharmacies in Connecticut, Delaware, New Jersey and Pennsylvania.
Clinical Specialties Compounding Pharmacy Voluntarily Recalls Lots of Avastin Injectable
Clinical Specialties, a compounding pharmacy headquartered in August, Ga., issued a voluntary recall of 79 lots of syringes filled with bevacizumab, Avastin on March 18, reported Medscape.com; as with MedPrep Consulting's day earlier recall announcement, the FDA followed Clinical Specialties' recall with a recall alert of its own to ophthalmologists' offices and clinics who may have received distribution of the potentially tainted drug in Georgia, Indiana, Louisiana and South Carolina, dated from Dec. 18, 2012 to the present.
The pre-filled syringes in question are used exclusively by the eye specialists in an off-label use of the medication for treatment of neovascular age-related macular degeneration. Although there is a medication formulated for this use, the medication, Lucentis, costs approximately $2000 per dose versus Avastin, which costs $50 per dose.
Clinical Specialties issued the recall of bevacizumab when it learned that five patients who had received the injectable medication via the same procedure, all by the same physician, had developed internal eye infections. At this time, the exact source of the infection has not been identified, but both the FDA and the compounding pharmacy were taking no chances.
It's refreshing to note that both the compounding pharmacies involved and the FDA have taken prompt action in these issues. You have to wonder, though, if the anticipated increased oversight of compounding pharmacies after the fungal meningitis debacle is as stringent as is needed. It stands to reason that something is still not happening the way it should, or there wouldn't be mold -- visible mold -- in sterile solutions. If something in the compounding process does go awry, it should be the pharmacies themselves that find the problems via their quality control measures, not hospitals and physician offices.
- Pharmaceuticals & Drug Trials