Product: FLUOROURACIL (5-FU) SOLUTION   5% OPHTHALMIC 100 ML;  FLUOROURACIL (5-FU) SOLUTION IN ARTIFICIAL TEARS 1% OPHTHALMIC 15 ML; FLUOROURACIL (5-FU) SOLUTION, P.F. 0.001% (10MCG/ML) OPHTHALMIC 20 ML, 30 ML; FLUOROURACIL P.F. 5% INJECTABLE 1000 ML,500 ML,	600 ML; FLUOROURACIL SOLUTION PF 1% OPHTHALMIC 10 ML,  20 ML, 25 ML, 5 ML; FLUOROURACIL, P.F. 1% INJECTABLE 40 ML (12 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 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