Pharmaceutical Pharmakon Fails to Recall all Non-Expired Drug Products Intended to be Sterile – Then Changes its Mind

The FDA on April 11, 2016 notified pharmaceutical, Pharmakon Pharmaceuticals, Inc, Noblesville, IN that all sterile operations at their facility should cease until appropriate corrective actions have been implemented by the facility and recall all non-expired drug products that are intended to be sterile.  A day later (April 12, 2016), Pharmakon informed FDA that it would neither initiate a recall nor cease sterile production.  The FDA, on April 15, sent out an alert (Click Here)to health care professionals not to use drug products marketed as sterile from Pharmakon.

On Tuesday, April 19, 2016 Pharmakon issued a recall .  It appears that Pharmakon saw the error of their ways.