Product: THIOTEPA, LYOPHILIZED 15MG INJECTABLE	8 VIAL;  	  THIOTEPA, LYOPHILIZED 30MG INJECTABLE	4 VIAL  	8 VIAL;  THIOTEPA, LYOPHILIZED 60MG INJECTABLE	2 VIAL  (4 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