Published on October 22, 2012

St. Vincent's to Notify Patients in Drug Recall

As you may be aware, the U.S. Food and Drug Administration, Centers for Disease Control and Prevention and Florida Department of Health have been conducting an ongoing investigation of contamination at the NECC’s Framingham, Massachusetts facility.  On Oct. 4, the FDA advised providers not to use any NECC products.  On Oct. 6, NECC announced a recall of all its products.

Although St. Vincent’s HealthCare does not use the steroid injectables associated with the current meningitis outbreak, St. Vincent’s has used other products produced by the same company.  As a result of the ongoing investigation of NECC, the FDA recommended, as a matter of precaution, that all patients who were administered any NECC injectable product be notified.  St. Vincent’s is now in the process of contacting patients who may have received Vitamin K or Cardioplegia products from NECC.

While the FDA has not linked Vitamin K and Cardioplegia to the development of any particular infection, St. Vincent’s HealthCare is contacting several patients in an effort to be proactive regarding their care.  If patients develop any signs or symptoms of infection, they should seek immediate medical evaluation. 

The Department of Health will continue to post updates at http://newsroom.doh.state.fl.us/. If you have additional questions or concerns, please call the Florida Department of Health’s toll-free hotline at 1-866-523-7339.

To view the FDA's list of NECC products, please visit http://www.fda.gov/Safety/Recalls/ucm322979.htm.

 

We appreciate your support in this matter and we will keep you informed of any new information.

 

Additional Documents;

Sample Patient Letter

Department of Health Press Release

FDA NECC Drug Recall