Product: MIDAZOLAM 1MG/ML (5ML VIAL) INJECTABLE	100 ML;  MIDAZOLAM 1MG/ML INJECTABLE	100 ML  	  	108 ML  	1250 ML  	  	20 ML  	292 ML  	300 ML  	40 ML  	500 ML  	90 ML;  MIDAZOLAM 5MG/ML INJECTABLE	140 ML  	150 ML  	200 ML;  MIDAZOLAM HCL ***(10X10ML) 5MG/ML INJECTABLE	100 MLS  (13 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