St. Louis-based Mobius Therapeutics announced a voluntary recall of two lots of Mitosol, (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use because it cannot exclude the possibility that the lots may be non-sterile.
The product is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery, and the two lots were distributed to 20 states from Oct. 22, 2012 to December 14, 2012.
The two lots "may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use," according to the news release. Mobius has not received any report of adverse events related to the recall, according to the release.
Mobius has begun an investigation into the cause of the possible non-sterile lots.
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The product is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery, and the two lots were distributed to 20 states from Oct. 22, 2012 to December 14, 2012.
The two lots "may contain a strain of yeast on one or more parts in the kit and should be considered non-sterile and unsafe for use," according to the news release. Mobius has not received any report of adverse events related to the recall, according to the release.
Mobius has begun an investigation into the cause of the possible non-sterile lots.
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