Florida Department of Health Urges Patient Follow Up From NECC Products

FOR IMMEDIATE RELEASE                          

November 2, 2012

Contact: DOH Communications:

(850) 245-4111

FLORIDA DEPARTMENT OF HEALTH URGES PATIENT FOLLOW UP FROM NECC PRODUCTS
~Ongoing investigation into New England Compounding Center identifies additional contaminated medications~

TALLAHASSEE – The Florida Department of Health (DOH) today was informed by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) of additional contaminated medications from the New England Compounding Center (NECC). Continued product testing has identified bacterial contamination in unopened vials of betamethasone, an anti-inflammatory steroid, and cardioplegia solution, used in open heart surgery. These implicated lots were distributed and later recalled by NECC on Oct. 6, 2012.

The implicated lots are as follows:

Betamethasone: 08202012@141
Betamethasone: 07032012@22
Betamethasone: 07302012@52
Cardioplegia solution: 09242012@55

“The Department of Health has continued to share CDC guidance with any health care facility that received contaminated medications from NECC to ensure that health care professionals provide the timely care, proper follow-up and support to patients throughout this investigation,” said State Surgeon General and Secretary of Health Dr. John Armstrong. “All health care facilities in the state have been visited by state officials, and we urge patients who received any NECC medications in health care facilities since May 21, 2012, to remain vigilant for symptoms of infection.”

The CDC has not received reports of laboratory-confirmed cases of infection due to bacterial infection associated with these products. The bacteria discovered are commonly found in the environment and have been rarely reported as a cause of human disease. The Department continues to urge health care providers to diagnose and treat any symptomatic patients who have received any NECC products.

The CDC and FDA previously advised healthcare professionals to cease use of any product produced by NECC. On Oct. 15, FDA issued a MedWatch Safety Alert advising clinicians to follow-up with patients who received any injectable NECC product, including betamethasone or cardioplegia solution purchased from or distributed by NECC after May 21, 2012. The Department has contacted facilities by phone and in-person repeatedly over the past four weeks with these reminders.

The CDC continues to investigate reports of potential infections in patients receiving other NECC products. As of Nov. 1, the CDC has received no reports of confirmed infections resulting from injection of any NECC product except those from the three recalled lots of preservative-free methylprednisolone acetate.