A third compounding pharmacy is recalling sterile injectable drugs nationwide because it can't rely on the results of an outside laboratory that tested them for sterility. The recall comes as the FDA is applying more heat to this niche of the drugmaking market despite the lack of its clear authority to do so. The agency filed a warning letter against another compounder this week, but in it acknowledged there are questions about its powers to take action.
Birmingham, AL-based Medaus Pharmacy today said it is is voluntarily recalling 11 products, including lipo injections with lidocaine, because it was unable to confirm testing "was conducted in a manner consistent with the highest standards of excellence we demand from ourselves and on behalf of our patients." The compounder did not name the outside lab.
Two other compounders, Birmingham, AL-based Wellness Pharmacy and JCB Laboratories of Wichita, KS, both recalled 6 lots of products last week because of concerns about testing by Front Range Laboratories of Loveland, CO. Questions about outside lab testing may become more important as the FDA skirmishes with yet another Texas compounding pharmacy that claims the FDA has no real authority to ask it to recall products.
Read more: Another compounder recalls drugs because of lapse in outside testing - FiercePharma http://www.fiercepharma.com/story/another-compounder-recalls-drugs-because-lapse-outside-testing/2013-09-06#ixzz2e7u0E9RM
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