Regulators Reach Agreement Over Ameridose Shipments to Fla.

TALLAHASSEE, Fla. The Florida Department of Business and Professional Regulation (DBPR) today announced that it has reached an agreement with Ameridose, LLC, temporarily halting all shipments from the company to facilities in Florida. Under the agreement, Ameridose will cease all dispensing or wholesale distribution of any products into the state of Florida effective immediately. Ameridoses 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 is currently working with the Massachusetts Board of Pharmacy to identify facilities in Florida which may have received products from Ameridose. Once these establishments have been identified, DBPR will work with the facilities to ensure that the products have been separated and 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 at: http://bit.ly/TsNaDf

Ameridose currently holds two non-resident prescription drug manufacturer permits from DBPR. Those permits have been restricted under the current agreement.

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Regulators Reach Agreement Over Ameridose Shipments to Fla.