Product: LIDOCAINE/TETRACAINE OPHTHALMIC 4%/0.5% SOLUTION	10 ML  	15 ML  	20 ML  	200 ML  	240 ML  	300 ML  	  	400 ML  (7 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