Mobius Therapeutics voluntarily recalls Mitosol® kit for ophthalmic use

Mobius Therapeutics, LLC, of St. Louis, MO, announced Jan. 10, 2013, that it is conducting a voluntary recall of two lots of its Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company is taking this voluntary action because it cannot exclude the possibility that the affected lots may be non-sterile. The two lots of Mitosol 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® is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. Optometrists may have occasion to see patients on whom this product has been used by a surgeon, the AOA Clinical Resources Group notes.

Use of these potentially contaminated products could result in serious eye problems/infections, including possible blindness. Mobius has not received any report of adverse events related to this recall. The potentially infected product is identified with lot numbers M098260 and M086920, bearing an expiration date of August 2013.

These lots were distributed between Oct. 22, 2012 and Dec. 14, 2012. in the following states: AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, and WI.

Mobius has contacted all affected customers by phone call, e-mail and written notification and they are arranging for return of unused product and replacing with product from unaffected lots.

Questions may be directed to Mobius by dialing 1-877-EYE-MITO (1-877-393-6486) and pressing option "2", Monday to Friday, 8:00 am to 5:00 pm CST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

December 14, 2012