Joint Statement from the Florida Department of Health and the Florida Department of Business and Professional Regulation on the Meningitis Outbreak
October 6, 2012
TALLAHASSEE, FL – Based on the latest information from the Centers for Disease Control and Food and Drug Administration, the Department of Health and the Department of Business and Professional Regulation today strongly advise all Florida health care facilities and practitioners to stop using any products from the New England Compounding Center (NECC). These products should be pulled from shelves immediately and not used until the CDC and the FDA make determinations that the products are safe.
This recommendation is in addition to the recall of three lots of NECC Methylprednisolone Acetate received in Lot Nos. 05212012@68, 06292012@26 and 08102012@51 which should be returned in accordance with FDA recall procedures. These three lots have been associated with Aspergillus meningitis following epidural back injections. These medications are not used for epidural analgesia in labor and delivery. This meningitis is not contagious and cannot be spread from person-to-person.
Any patients known or suspected to have received back injections with NECC Methylprednisolone Acetate from the suspected lots should be evaluated immediately by their health care professional and monitored or treated as necessary. The FDA’s list of recalled products related to the meningitis outbreaks is online.
The departments have notified all eight Florida facilities who received contaminated Methylprednisolone Acetate, and all suspected lots have been removed. The departments continue to communicate jointly to all other facilities that may have any products from the NECC. Facilities and practitioners should immediately stop using any NECC products until the CDC and the FDA make determinations that the products are safe. A list of facilities who may have received any products from the NECC is online.
The Department of Health has set up a toll-free hotline at 1-866-523-7339 for those who may have additional questions. Health care facilities with questions about how to identify affected products or how to dispose of any products may visit the Division of Drugs, Devices and Cosmetics' webpage for additional information.
The Division of Drugs, Devices and Cosmetics safeguards the health, safety and welfare of the citizens of the state of Florida from injury due to the use of adulterated, contaminated or misbranded drugs, drug ingredients and cosmetics by administering the provisions of the Florida Drug and Cosmetic Act (Chapter 499, F.S.).