Product: MITOMYCIN 1MG/ML SOLUTION	160 ML  	  	  	  	  	  	  	  	  	  	  	40 ML  	  	  	  	  	  	80 ML;  	  	  	  	  MITOMYCIN SOLUTION, STERILE 0.02% (200MCG/ML) OPHTHALMIC	0.5 ML  	  	  	  	  	1 ML  	  	  	  	  	  	  	  	1.5 ML  	  	  	  	  	10 ML  	  	  	  	  	  	  	  	12.5 ML  	2 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	2.5 ML  	  	  	3 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	30 ML  	4 ML  	  	  	  	5 ML  	  	  	  	  	  	  	  	  	  	  	  	6 ML  	  	  	  	7 ML;  MITOMYCIN SOLUTION, STERIL
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