Missouriwatcher
Editor, Senior Moderator
January 10, 2013 - Mobius Therapeutics, LLC, St. Louis, MO, announced today 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 is taking this voluntary action due to the fact that we 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.
Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. 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. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6486, Option 2, for safe return of the product.
The impacted product is identified below:
NDC # Lot # Exp Date Product Description
49771-002-01 M098260 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
49771-002-01 M086920 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
These lots were distributed 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.
Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.
http://www.fda.gov/Safety/Recalls/ucm335055.htm
Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. The user level for this product would be physicians in hospitals and clinics during surgery. 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. Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6486, Option 2, for safe return of the product.
The impacted product is identified below:
NDC # Lot # Exp Date Product Description
49771-002-01 M098260 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
49771-002-01 M086920 08/2013 Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use
These lots were distributed 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.
Mobius has initiated an investigation to determine the root cause and corrective and preventative actions.
http://www.fda.gov/Safety/Recalls/ucm335055.htm