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

January 10, 2013

Audience: Ophthalmology

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 this recall.

RECOMMENDATION: Customers with affected product in their possession should stop using the product immediately and contact Mobius at 1-877-393-6484, Option 2, for safe return of the product. 

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[1/10/12 - Firm Press Release - Mobius]

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