The U.S. Food and Drug Administration released an alert to pharmacy, nursing and infectious disease personnel to immediately stop using any sterile products manufactured by I.V. Specialty on March 9. An investigation found insanitary conditions and poor sterile production practices that could put patients at risk for infection. It has not stopped manufacturing and distributing the pharmaceuticals, despite an FDA recommendation.
The company manufactures home infusion therapies, including antibiotics, pain medication, chemotherapy drugs and offers are cardiac care line for heart transplants candidates, among other drugs.
Officially, the FDA reported:
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 are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor 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 I.V. Specialty.
- Background: During FDA’s recent inspection of I.V. Specialty, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about I.V. Specialty’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.
- Recommendation: Healthcare professionals and consumers should immediately check their medical supplies, quarantine any drug products labeled as sterile from I.V. Specialty, and not administer them to patients. Healthcare professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.