Product: ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE	200 ML  	40 ML  	400 ML  	48 ML  	600 ML  	800 ML;  ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE	20 ML  	  	  	  	200 ML  	24 ML  	40 ML  	48 ML  (11 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