Product: IOPAMIDOL 41% INJECTABLE	198 ML  	  	99 ML  	50 ML  	600 ML  	72 ML;  	  	  	  IOHEXOL,  4ML VIAL 240MG IODINE/ML INJECTABLE	200 ML;  IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE	180 ML  	600 ML  	  	90 ML  	  	  	  	  	900 ML  (2 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