2nd Massachusetts-based compounding co. issues recall
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2nd Massachusetts-based compounding co. issues recall Ameridose, a sister company of the firm associated with the ongoing fungal meningitis outbreak, is voluntarily recalling all of its unexpired drug products in response to preliminary concerns from the US FDA. The FDA, together with the State of Massachusetts, is currently conducting an inspection of the Ameridose facility in Westborough, Massachusetts. While the inspection is still ongoing, preliminary findings have raised concerns about a lack of sterility assurance for products produced at and distributed by the facility. The FDA says that the recall is out of an "abundance of caution", and is not based on any reports of infections associated with any Ameridose product. Ameridose shares common management with the New England Compounding Center (NECC), which is currently under investigation following reports of fungal meningitis in patients who received epidural steroid injections compounded at its facility in Framingham, Massachusetts.* * see Reactions 1426 p1; 803079396 FDA. FDA reports voluntary recall of all Ameridose drug products. Media Release 809142903 : 31 Oct 2012. Available from: URL: http://www.fda.gov
0114-9954/10/1427-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 10 Nov 2012 No. 1427
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