FDA Advises Against Use of Drug Products Intended to be Sterile from Promise Pharmacy
- Food and Drug Administration
- All Healthcare Organizations
The U.S. Food and Drug Administration (FDA) 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 f…