State: Second Company Issues Voluntary Product Recall
Company with management associated with the New England Compounding Center has recalled products
November 1, 2012
TALLAHASSEE, Fla. – The Florida Department of Health (DOH) and the Florida Department of Business and Professional Regulation (DBPR) today announced that a second Massachusetts company has issued a voluntary recall of its products. Ameridose, LLC, based in Westborough, Massachusetts, is voluntarily recalling all of its unexpired products in circulation. The company’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.
According to the Food and Drug Administration (FDA), its preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by the Ameridose facility. 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/.
The company currently holds two non-resident prescription drug manufacturer permits from DBPR and two compounding pharmacy licenses from DOH. The company does not have any physical locations in Florida. DBPR is in the process of 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, therefore, the FDA has recommended that health care professionals do not need to follow up with patients who have received Ameridose products at this time. However, any patients who are experiencing any adverse effects from the products should contact their health care professionals immediately.
The DOH and DBPR will continue to update department websites at http://newsroom.doh.state.fl.us/ and http://www.myfloridalicense.com/dbpr/. DOH also has a toll-free hotline at 1-866-523-7339 for those who may have additional questions.