Product: POVIDONE-IODINE OPHTHALMIC 5% SOLUTION	10 ML  	  	125 ML  	15 ML  	  	40 ML  	50 ML;  POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC	100 ML  	120 ML  	  	  	  	  	200 ML  (8 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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated: 20120521
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated