[03/09/2016] The U.S. Food and Drug Administration 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.  

Health care 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.  Health care professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

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.

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.

To date, FDA is not aware of any reports of adverse events associated with drug products produced by I.V. Specialty.  Patients who have received drug products produced by I.V. Specialty 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 human drug products from I.V. Specialty to FDA’s MedWatch Adverse Event Reporting program: 

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or

• Download and complete the form, then submit it via fax at 1-800-FDA-0178

For reporting animal adverse drug events, please follow the link to the FORM FDA 1932a found at: How to Report Animal Drug and Device Side Effects and Product Problems