Product: METHYLCOBALAMIN/FOLIC ACID - KIT 10MG/0.4MG/ML INJECTABLE	1 KIT  	  METHYLCOBALAMIN/FOLIC ACID 1000MCG/0.4MG/ML INJECTABLE	10 ML  	  METHYLCOBALAMIN/FOLIC ACID 10MG/0.4MG/ML INJECTABLE	10 ML  	  	  	  	8 ML  	8 MLS
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