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Clinical Specialties Recalls Eye Drugs in Another Sterility Scare



3/21/2013 8:09:10 AM

Sterility problems persist at compounding pharmacies six months after the fungal meningitis outbreak, with yet another safety alert issued this week. The latest contamination is the result of a cost-saving measure — similar to one that resulted in the death of an East Nashville man last summer. After five people suffered eye infections, Clinical Specialties of Augusta, Ga., on Monday recalled shipments of Avastin injections that it had remixed into smaller doses. Three days earlier, Med Prep Consulting Inc. of Tinton Falls, N.J., suspended operations after fungal particles were observed floating in one of its IV medications. Although the U.S. Food and Drug Administration has increased inspections of pharmacies that remix brand-name medications or make non-patented drugs, agency officials say they need clearer authority. The two most recent recalls occurred after medical providers — not the FDA — spotted problems. Federal and state officials are still mulling over how to better regulate compounding pharmacies. The outbreak stemming from steroid medicine made by New England Compounding Center has sickened more than 700 people. Fifty have died. “We need the FDA to step in,” said Michael Cohen, president of the Institute for Safe Medication Practices. “If we don’t have an infrastructure that we can trust, and we can’t get essential drugs we need from traditional manufacturers, patients are always going to be at risk.” Med Prep Consulting has recalled all of its products as a precaution. The drug with the floating particles, magnesium sulfate, was shipped to New Jersey, Pennsylvania, Connecticut and Delaware. “Magnesium sulfate is an essential product for magnesium replacement, prevention of seizures in pregnant women with pre-eclampsia and has other uses,” Cohen said. “If people can’t get it from traditional manufacturers, they either have to make it themselves or get it from a compounder. In this case, hospitals around the country needed it.”

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