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FDA Medwatch Alert: Mobius brand Mitosol (mitomycin for solution) Kit for Ophthalmic Use: Recall-May Not be Sterile

Posted 11 Jan 2013 by Drugs.com

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 ... Read more

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