[11-15-2015]The U.S. Food and Drug Administration is alerting health care professionals and patients not to use drug products within expiry that are intended to be sterile and are produced and distributed by Cape Apothecary Inc., in Annapolis, MD, due to lack of sterility and quality assurance.
Health care professionals and patients should immediately check their medical supplies, quarantine any drug products marketed as sterile from Cape Apothecary, and not administer them. 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 Cape Apothecary’s facility, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Cape Apothecary’s ability to assure the sterility of drug products that it produced.
On November 5, 2015, FDA recommended that Cape Apothecary cease sterile operations until appropriate corrective actions have been implemented by the facility and recall all drug products within expiry that are intended to be sterile. On November 5, 2015, Cape Apothecary informed FDA that it would voluntarily recall all drug products intended to be sterile and cease production of sterile products until adequate corrective actions have been implemented and verified by FDA.
The company has not yet initiated the recall. Therefore, FDA alerts health care professionals and patients not to use drug products marketed as sterile from Cape Apothecary.
To date, FDA is not aware of any adverse events associated with drug products made by Cape Apothecary. Patients who have received drug products produced by Cape Apothecary and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program: