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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 only said: "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 said it would post a list of the products it's recalling on its website later Wednesday.
Ameridose makes an array of injectable drugs, which are used for a variety of purposes, including in anesthesia or to correct acid imbalances in the body during critical care.
Ameridose agreed to shut down for inspection in October after tainted steroids from the New England Compounding Center were linked to a fungal meningitis outbreak that's spread to 19 states, sickening 377, 29 of whom have died.
Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. Since the outbreak, Cadden, the lead pharmacist at NECC, has resigned from Ameridose.
This program aired on October 31, 2012. The audio for this program is not available.
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