Product: FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/10MG VIAL INJECTABLE 12 VIAL, 20 VIAL, 24 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/15MG VIAL INJECTABLE 23 VIAL, 25 VIAL, 30 VIAL, 7 VIAL; FLUORESCEIN/INDOCYANINE, LYOPHILIZED 200MG/5MG VIAL INJECTABLE 1 VIAL, 10 VIAL, 12 VIAL, 13 VIAL, 15 VIAL, 2 VIAL, 20 VIAL, 24 VIAL, 3 VIAL, 30 VIAL, 40 VIAL, 41 VIAL, 5 VIAL, 50 VIAL, 6 VIAL, 7 VIAL, 9 VIAL;  FLUORESCEIN/INDOCYANINE, LYOPHILIZED 300MG/5MG VIAL INJECTABLE 10 VIAL, 15 VIAL, 20 VIAL; FLUORESCEI
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