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DESI + non-cGMP = Recall

FDA is clamping down  on DESI’s, but to date we have seen FDA only stop manufacturing and distibution.  Until now.  On April 20, 2009, Neilgen Pharmaceuticals and its parent Advent Pharmaceuticals were forced into a recall of 13 cough/cold medications.  All of the cough cold medications are tannate salts of common ingredients.  It is one thing to halt manufacturing but is a very expensive proposition to recall products.  The recall affects all products shipped since March 5.

Normally, FDA cannot force a firm into a recall.  By law, recalls are voluntary.  In this case, FDA went to court over cGMP violations and the recall appears to be part of a consent order.