Ameridose Recalls All Products After FDA Raises Concerns

Following an FDA inspection, Ameridose, LLC, has issued a voluntary recall of all its products, reports Boston.com. Federal investigators identified shortcomings in testing procedures which prompted the company to undertake precautions to ensure sterile products. According to Dr. Janet Woodcock, the director of the FDA Center for Drug Evaluation and Research, no contaminated products were found in Ameridose products. However, they were not assured in their testing procedures and found multiple sources of possible contamination in the pharmacy’s rooms.

Ameridose has already suspended operations while authorities investigated its operations. The company maintains that the New England Compounding Center, which is responsible for the meningitis outbreak around the country, is not reflective of conditions within the Ameridose company.

Source:

• http://www.boston.com/whitecoatnotes/2012/10/31/ameridose-recalls-all-drugs-after-fda-finds-problems-with-its-sterility-testing/Yno31L2Aw7LeAjOElo0DnO/story.html