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BLIND IF YOU DO AND BLIND IF YOU DON T


Think Glaucoma’s blindness is bad? What about the eye problems/infections, including possible blindness complications that could come from a defective drug used in glaucoma surgery? At least the glaucoma is treatable with surgical procedures.

Mobius Therapeutics, LLC issued a voluntary recall of its Mitosol® (mitomycin for solution Kit for Ophthalmic Use on January 10, 2013. Mobius Therapeutics, recalled lots of its Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use due to the fact that it could not exclude the possibility that the affected lots may be non-sterile and unsafe for use.
Mitosol is an antimetabolite product used in ab externo glaucoma surgery where the incisions are made from the outside of the eye inward. A non-steril dose of this product could result in serious eye problems/infections, including possible blindness. Mobius says it has not received any reports of adverse events related to this recall, but there are thousands of affected doses. The impacted product is identified below:
NDC # Lot # Exp Date
49771-002-01 M098260 08/2013
49771-002-01 M086920 08/2013

Further, these lots were distributed for a 2 month period in the following states:
AL, AR, DE, GA, IL, IN, MA, MD, ME, MI, MN, MO, NC, NJ, NY, OH, PA, TN, VA, & WI
between the dates of 10/22/2012 and 12/14/2012.

What caused the defective non-steril product? Poor manufacturing practices. If you or a loved one suffered serious eye problems/infections, including possible blindness after glaucoma surgery between October 22, 2012 January 10, 2013, it may be related to this product defect.