ISSUE: Mobius Therapeutics announced that it is conducting a voluntary recall of 2 lots of Mitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use. The company cannot exclude the possibility that the affected lots may be non-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. Use of these products could result in serious eye problems/infections, including possible blindness.
BACKGROUND: The Mitosol Kit for Opthalmic Use is an antimetabolite indicated as an adjunct to glaucoma surgery. The recalled lot numbers and a list of the 20 states to which the product was distributed are listed in the firm press release. The recalled product was distributed between 10/22/2012 and 12/14/2012. Mobius has not received any report of adverse events related to this recall.
RECOMMENDATION: Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484, Option 2, for safe return of the product.
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