Product: SODIUM BICARBONATE 4% INJECTABLE	10 ML  	  	5 ML;  SODIUM BICARBONATE 8.4% INJECTABLE	150 ML  	50 ML  	5000 ML;  SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE	100 MLS  	250 ML;  SODIUM BICARBONATE, MDV 8.4% INJECTABLE	100 ML  	  	150 ML  	200 ML;  	  SODIUM CHLORIDE  0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE	25 VIAL  	40 ML;  SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION	1000 ML  	2500 ML;  SODIUM CHLORIDE 0.9%  BACTERIOSTATIC ** 0.9% INJECTABLE	30 MLS  	750 ML;  SODIUM CHL
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