Product: MANNITOL 20% INJECTABLE	1250 ML  	  	250 ML  	  	2500 ML  	  	400 ML;  	  MANNITOL 25% INJECTABLE	1200 ML  	  	300 ML  	  	  	  	350 ML  	400 ML  	600 ML  (9 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