Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance

AUDIENCE: Pharmacy, Health Professional, Patient

ISSUE: FDA is alerting health care professionals 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, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces.

Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.

BACKGROUND: On July 31, 2017, FDA recommended that Atlantic Pharmacy cease 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. Therefore, FDA is 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.

RECOMMENDATION: Health care professionals and patients should immediately check their medical supplies, quarantine any drug products labeled as sterile from Atlantic Pharmacy, and not administer them to patients. Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570944.htm.