Product: TROPICAMIDE/PHENYLEPHRINE  OPHTHALMIC 15:1 SOLUTION	128 ML  	480 ML  	496 ML  	576 ML  	  	90 ML  (5 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