FDA alert: Lack of sterility assurance for sterile drug products from Vital Rx, dba Atlantic Pharmacy and Compounding

FDA is cautioning health care providers and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, due to a lack of sterility assurance.

FDA is cautioning health care providers and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, due to a lack of sterility assurance. FDA investigators observed during a recent inspection of Atlantic Pharmacy insanitary conditions, including poor sterile production practices. The agency recommended on July 31, 2017 that Atlantic Pharmacy halt sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has not yet initiated a recall. FDA is therefore alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by Atlantic Pharmacy.