Product: BUDESONIDE (P.F) NASAL IRRIGATION 0.5MG/500ML  SOLUTION	1000 ML; BUDESONIDE (P.F) NASAL IRRIGATION 0.6MG/50ML  SOLUTION 1500 ML (2 DIFFERENT UNITS)
Reason for recall: Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated: 20120525
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated