Product: LEVOFLOXACIN, P.F. (PREMIXED SOLUTION) 5MG/ML  INJECTABLE	1200 ML  	500 ML  	700 ML  	  	800 ML  LEVOFLOXACIN, P.F. 25MG/ML(500MG/20ML) INJECTABLE	300 ML  	500 ML  (6 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