Product: KETOROLAC TROMETHAMINE 30MG/ML INJECTABLE	10 ML  	  	  	24 ML  	  	500 ML;  KETOROLAC TROMETHAMINE 60MG/ML INJECTABLE	48 ML;  KETOROLAC TROMETHAMINE, 1ML SDV**25X1ML 30MG/ML INJECTABLE	50 ML  	  	  	75 ML;  KETOROLAC TROMETHAMINE, P.F. 60MG/ML INJECTABLE	10 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