A company with the same founders as the pharmacy linked to deadly meningitis outbreak said today that it's recalling all its products after federal inspectors said it must improve its sterility testing. An FDA official said she could not be specific about the problem at Ameridose, which, like the New England Compounding Center, is based in Massachusetts. She would only say: "We found there was not adequate assurance of sterility in their sterile products." The agency knows of no infections linked to the recalled products.
In a statement, Ameridose said it issued the recall "out of an abundance of caution." The company makes an array of injectable drugs, which can be used in anesthesia or to correct acid imbalances in the body during critical care. (The full list is here.) Ameridose agreed to shut down for inspection earlier this month after tainted steroids from the NECC were linked to a fungal meningitis outbreak that's spread to 19 states and killed 29. Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with distinct management. (More meningitis stories.)
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