From the American Academy of Ophthalmology

Mobius Therapeutics is conducting a voluntary recall of two lots of Mitosol® (mitomycin for solution), 0.2 mg/via, Kit for Ophthalmic Use. The company said in a press release distributed Thursday that it is taking the action as it cannot exclude the possibility that the affected lots may be non-sterile. The lots may contain a strain of yeast on one or more parts in the kit and should be considered unsafe for use. Mobius has not received any reports of adverse events related to this recall, but use of the product could result in serious eye problems and infections, including blindness.

The recalled lot numbers and a list of the 20 states where the product was distributed are on the Mobius Therapeutics website. Customers with affected kits in their possession should stop using the product immediately and contact Mobius at 877.393.6484, option 2, for safe return.

Any adverse events or side effects related to use of the Mitosol product should be reported to the U.S. Food and Drug Administration’s MedWatch Safety Information and Adverse Event Reporting Program:

• Online at www.fda.gov/MedWatch/report.htm;or
• Download or call 800.332.1088 to request a reporting form. Return the form to the address provided therein or fax to 800.332.0178.

For more information, contact the Academy’s Governmental Affairs division at 202.737.6662.