FDA alerts health care professionals and patients not to use drug products intended to be sterile from Promise Pharmacy
Compounded drugs were produced under poor sterile product ion practices in an inadequately designed processing room [12/7/2018] The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products intended to be sterile that were produced in an inadequately designed processing room and distributed by Promise Pharmacy, Palm Harbor, Florida, due to lack of sterility assurance. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. During FDA’s recent inspection of Promise Pharmacy’s facility, investigators observed insanitary conditions, including poor sterile product ion practices and inadequate design of one of its processing rooms, which raised concerns about the company’s abilit...