Mitosol recall

Mobius Therapeutics, LLC today announced a voluntary recall of two lots of Mitosol (mitomycin solution), 0.2 mg/vial, Kit for Ophthalmic Use. The lots may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe. The impacted lot numbers are M098260 and M086920.

Mitosol is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484 for safe return of the product. 

The recalled lot numbers and a list of the 20 states where the product was distributed are on the Mobius Therapeutics website.

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.