Mitosol Kit for Ophthalmic Use for Glaucoma Surgery Recalled Because May Not Be Sterile; Use May Cause Blindness

Two lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use, manufactured by Mobius Therapeutics, LLC, St. Louis, Missouri, have been recalled because they may not be sterile. These two lots of Mitosol (mitomycin for solution) Kits may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use.


Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. Physicians in hospitals and clinics during surgery use this product. Use of these potentially contaminated products could result in serious eye problems or infections, including possible blindness.


These lots were distributed in Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin. And, were distributed between the dates of October 10, 2012 and December 14, 2012.


See the Recall