State Regulators Extend Agreement with Ameridose Halting Company’s Shipments to Florida
November 19, 2012
TALLAHASSEE, Fla. – The Florida Department of Business and Professional Regulation (DBPR) today extended a previous agreement with Ameridose, LLC, halting all shipments from the company to facilities in Florida. Under the agreement, Ameridose will not dispense or distribute any products into the state of Florida through December 31, 2012. Ameridose’s management is associated with the New England Compounding Center (NECC), the compounding pharmacy linked to the ongoing outbreak of fungal meningitis from contaminated medications.
On October 31, 2012, Ameridose issued a voluntary recall of its unexpired products in circulation. Health care professionals should cease using any products from Ameridose at this time and should return the products to the company. Facilities with Ameridose products, which may include hospitals, clinics and other establishments, should contact the company at 888-820-0622 for instructions on how to return the products. A complete list of recalled products subject to this recall is available at http://www.ameridose.com/news/.
DBPR has identified nearly 200 facilities in Florida which may have received products from Ameridose. DBPR is in the process of contacting each facility to ensure they are aware that the products must be separated and that recall procedures are being followed.
No infections that link back to Ameridose medications have been reported at this time, therefore, the FDA has recommended that health care professionals do not need to follow up with patients who have received Ameridose products. However, any patients who are experiencing any adverse effects from the products should contact their health care professionals immediately.
A copy of the agreement is available online.
Ameridose currently holds two non-resident prescription drug manufacturer permits from DBPR. Those permits have been restricted under the current agreement.