Product: GENTAMICIN  40MG/ML (80MG/2ML) INJECTABLE 20 ML, 40 ML, 48 ML, 50 ML;  GENTAMICIN / SODIUM BICARBONATE (STERILE) 480MG/LITER SOLUTION 1000 ML; GENTAMICIN /CLINDAMYCIN /POLYMIXIN B/STERILE WATER  0.1%/0.1%/0.05% SOLUTION 250 ML, 500 ML; GENTAMICIN DROPS (FORTIFIED) 14MG/ML (1.4%) OPHTHALMIC 10 ML; GENTAMICIN DROPS (FORTIFIED) 15MG/ML (1.5%) OPHTHALMIC 10 ML, 15 ML; GENTAMICIN DROPS (FORTIFIED) 18MG/ML (1.8%) OPHTHALMIC 5 ML; GENTAMICIN IRRIGATION 1GM/LITER SOLUTION 2000 ML; GENTAMICIN IRRIGATION 
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Recall initiated: 20120525
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated