Product: PHENTOLAMINE 10MG/ML INJECTABLE	6 ML;  	  PHENTOLAMINE 1MG/ML INJECTABLE	2 ML  	5 ML;  PHENTOLAMINE 5MG/ML INJECTABLE	20 ML  	50 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