BOSTON (AP) — In a story and in a separate list Oct. 31 about a nationwide fungal meningitis outbreak, The Associated Press, relying on information from the Centers for Disease Control and Prevention, erroneously reported that 29 people have died. The correct death toll is 28.
A corrected version of the story is below:
Mass. firm tied to closed pharmacy issues recall
Mass. firm with ties to outbreak-linked pharmacy issues voluntary recall of all products
BOSTON (AP) — A company with the same founders as the specialty pharmacy linked to deadly meningitis outbreak said Wednesday that it's recalling all its products after federal inspectors said it must improve its sterility testing process.
Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration, said she could not be specific about the problem at Ameridose. She would only say: "We found there was not adequate assurance of sterility in their sterile products."
Woodcock stressed the agency knows of no infections linked to the recalled products. In a statement, Westborough-based Ameridose said it issued the recall "out of an abundance of caution."
"Ameridose and FDA agree that the use of injectible products that are not sterile can represent a serious hazard to health and could lead to life-threatening injuries and/or death," the company said. "We are undertaking this recall to assure customers that when Ameridose products are shipped, they are fully in conformance with all of the FDA's recommendations."
The company posted a lengthy list of the recalled products, including painkillers, anesthetics and blood thinners, on its website Wednesday.
Woodcock said the large recall could exacerbate some shortages for critically needed drugs and the agency is working to head off any supply problems.
An FDA spokeswoman said among the steps the agency can take is to ask manufacturers to increase production or help them solve quality problems that are stopping production. It can also look for viable overseas producers if no domestic manufacturers are available.
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