Product: CYCLOSPORINE (A) AQUEOUS (HUMAN)  0.5% OPHTHALMIC 10 ML,	5 ML;  CYCLOSPORINE (A) AQUEOUS PF   (HUMAN)  0.2% OPHTHALMIC 10 ML;  CYCLOSPORINE (A) AQUEOUS PF (HUMAN)  1% OPHTHALMIC 10 ML;  CYCLOSPORINE (A) CORN OIL SOLUTION 2% OPHTHALMIC 15 ML; CYCLOSPORINE (A) OIL SOLUTION 1% OPHTHALMIC 10 ML, 20 ML, 60 ML;  CYCLOSPORINE (A) OIL SOLUTION 2% OPHTHALMIC 10 ML, 15 ML, 20 ML, 30 ML (12 DIFFERENT PRODUCTS)
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