Product: VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. (BSS) 0.4% (4MG/ML) (0.4MG/0.1ML) INJE	400 ML;  VANCOMYCIN (INTRAOCULAR) OPHTHALMIC, P.F. 1MG/0.1ML (10MG/ML) INJECTABLE	0.1 ML  	  	  	  	  	0.2 ML  	1 ML  	100 ML  	150 ML  	2 ML  	  	2 MLS  	5 ML  	50 ML  	6 ML  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	95 ML;  VANCOMYCIN HCL, FTV** 1GM INJECTABLE	3 VIAL  	4 VIAL;  VANCOMYCIN, FORTIFIED 1% (10MG/ML) OPHTHALMIC	10 ML;  	  	  	  VANCOMYCIN, FORTIFIED 1.5% (15MG/ML) OPHTHALMIC	15 ML;  VANCOMYCIN, FORTIF
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