Company Recalls Two Mitosol Lots
Mobius Therapeutics LLC today announced a recall (PDF) of Mitosol Kit for Ophthalmic Use lots M098260 and M08692 because one or more parts in the kits may contain a strain of yeast.
The company said all customers affected by the recall have been contacted.
Initial distribution of the two lots occurred from October 22 to December 14, 2012.
Mitosol contains lyophilized mitomycin for use during certain glaucoma surgeries. The product's instructions for use state that the kit's inner tray, containing the drug vial, sponges, and other material, is sterile. This sterile inner tray is packaged in an outer pack that a circulating nurse opens in the operating room.
Mobius markets the product, which is manufactured by Intas Pharmaceuticals Ltd., a subsidiary of Accord Healthcare Ltd.