Mitosol Recall Issued Due to Risk Some Lots May Not Be Sterile

Mobius Therapeutics is recalling two lots of Mitosol, a drug used in glaucoma surgery, because it may be contaminated with a strain of non-sterile yeast. 

The Mitosol recall was announced by the FDA and St. Louis-based Mobius on January 10, although there have been no illnesses reported in connection with the product.

The recalled Mitosol was sold in kits for ophthalmic use. Mobius warns that part of the kits may contain a strain of yeast and should be considered unsafe. If the products are contaminated and used, they could cause eye problems for patients, including eye infections and blindness.

The recall affects two lots of Mitosol (mitomycin for solution), o.2 mg/vial, kit for Ophthalmic use. One has a lot number of M098260 and the other has a lot number of M086920. Both have an an NDC number of 49771-002-01 and a expiration date of 08/2013.

The company says the drugs were distributed to Alabama, Arkansas, Delaware, Georgia, Illinois, Indiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia, and Wisconsin between October 22, 2012 and December 14, 2012.

Mobius says it has initiated an investigation to uncover the cause of the possible contamination and the company has contacted all affected customers by phone , e-mail and written notification to warn them of the recall and make arrangements for the drugs to be returned.

Customers with questions can contact Mobius by calling (877) 393-6484 or (877) 393-6486 and pressing Option 2. Anyone who has experienced an adverse effect from the recalled drugs should contact the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm.