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Mobius Therapeutics voluntarily recalls Mitosol® ophthalmic-use kit

January 10, 2013

Mobius Therapeutics announced 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. Some surgeons use the drug in cataract and refractive surgeries. 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 noted.

Mitosol® is an anti-metabolite reconstituted and applied, by a topical saturated sponge, to the surgical site of glaucoma filtration surgery and some posterior flap laser flash procedures (post-LASIK for persistent DLK). It is not intended for intraocular administration. Other instances where this anti-metabolite is used may include post-pterygium removal.

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: Alabama, Arkansas, Deleware, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin.

Mobius has contacted all affected customers by phone, email and in writing and is arranging for return of unused product and replacement with product from unaffected lots.

For more information, call 877-EYE-MITO (877-393-6486) and select “2” Monday to Friday from 8 a.m. to 5 p.m. CST.

Adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration’s MedWatch Adverse Event Reporting program online, by mail or fax.

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