Mobius Theraputics™ Provides Update on Recall of Two Lots of Mitosol®
Published: Feb 20, 2013
ST. LOUIS, MO--(Marketwire - February 20, 2013) - Mobius Therapeutics, the makers of Mitosol® (mitomycin for solution) Kit for Ophthalmic Use, announced today that the source for the recent voluntary recall of two lots was likely due to laboratory contamination induced at the time of testing.
"Upon investigation, we have determined conclusively that, during testing, a technician contaminated the sterility of the items that tested positive," said Ed Timm, President and CEO of Mobius Therapeutics. "As the Mobius investigation has determined that the contamination was induced post-sterilization, we now believe that this contamination was the likely source of the false positive result."
The testing procedure instructed sterile technicians to make physical contact with a non-sterile item (the outside of the sterile package) followed by immediate, consecutive contact with sterile kit components. By definition, this action contaminates the sterile components, making this action a likely source of organisms generating a false positive result.
"We are grateful to our testing laboratory for their exhaustive investigation," Timm continued. "While we had an inherent belief in the integrity of our processes, Mobius acted out of an abundance of caution in the interest of patient safety and worked with FDA in initiating a voluntary recall of the two lots in question."
About Mobius Therapeutics, LLC:
Mobius Therapeutics is a commercial stage venture focused on ophthalmic surgery solutions. Its first product, Mitosol®, is a system for delivering antifibrotic agents in glaucoma, refractive, and corneal surgery. The glaucoma indication is in active commercialization; the pterygium and refractive indications are awaiting approval by the Food and Drug Administration. Please see full prescribing information for Mitosol at www.MobiusTherapeutics.com. Mobius is housed within the Center for Emerging Technologies in St. Louis, Missouri.
Mobius Therapeutics, LLC
The Vandiver Group, Inc.