Tuesday, January 22, 2013

Mitosol® (mitomycin for solution) Recalled By Mobius Therapeutics, LLC, FDA

Mobius Therapeutics, LLC Issues a Voluntary Recall of Mitosol® (mitomycin for
solution), 0.2 mg/vial, Kit for Ophthalmic Use

Mobius Web Site
FOR IMMEDIATE RELEASE - 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 DateProduct Description
49771-002-01M09826008/2013Mitosol® (mitomycin for solution), 0.2 mg/vial, Kit for
Ophthalmic Use
49771-002-01M08692008/2013Mitosol® (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.
Mobius has contacted all affected customers by phone call, e-mail and written notification and they are arranging for return of unused product and replacing with product from unaffected lots.
Questions may be directed to Mobius by dialing 1-877-EYE-MITO (1-877-393-6486) and pressing option “2”, Monday to Friday, 8:00 am to 5:00 pm CST. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
    www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
  • Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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