Recall of Not-So-Sterile Drug Products

August 11, 2017

FDA is alerting health professionals to a sterility breach with Vital Rx Inc. products.

The FDA has issued an alert to health-care professionals about drug products produced and distributed by Vital Rx. Inc., which does business as Atlantic Pharmacy and Compounding in Pompano Beach, FL. The alert is due to a lack of assurance that the products are sterile.

In a statement, the FDA stated that a recent inspection of Atlantic Pharmacy found unsanitary conditions, including poor sterile production practices. The agency recommended that Atlantic Pharmacy cease production until corrective measures were taken and that it should recall all its non-expired drug products. However, the company has not initiated a recall, which prompted the FDA alert.

“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,” the FDA said in a statement. The agency added that health-care professionals and facilities should make arrangements to obtain any medications they administer 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:

  • 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.