Mitosol Ophthalmic Kit May Not be Sterile

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Mobius Therapeutics announced that it is conducting a voluntary recall of two lots of Mitosol (mitomycin for solution), 0.2mg/vial Kit for Ophthalmic Use due to the possibility that the affected lots may be non-sterile.  Mitosol Kit for Ophthalmic Use is an antimetabolite indicated as adjunct to glaucoma surgery.

The two lots of Mitosol Kits may contain a strain of yeast on one or more parts in the kit and should be considered unsafe for use. Use of non-sterile products could result in serious eye infections, including possible blindness.

The affected lot numbers are M098260 and M086920 with a 08/2013 expiration date. These products were distributed between the dates of 10/22–12/14/2012.

It is recommended that those with the affected product in their possession should stop using it immediately and call (877) 393-6484 for safe return of the product.

For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm335167.htm
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