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Recall of Newly Approved Glaucoma Medication Mitosol

According to a recent article in the St. Louis Business Journal, the St. Louis-based Mobius Therapeutics, LLC is conducting a voluntary recall of two lots of Mitosol, its newly approved Glaucoma medication.  Mobius warns that its Mitosol “Kit for Ophthalmic use” may not be sterile because it may contain a harmful strain of yeast.  According to the Food and Drug Administration (FDA), use of the recalled medication can cause serious eye problems and infections, including the possibility of blindness.

The FDA characterizes the drug as an “adjunct” to surgery for glaucoma, meaning that it’s a drug used during glaucoma surgery.

A History of Mitosol and its Use in Glaucoma Treatment

In February 2012, the FDA approved Mitosol.  Since its approval, Mobius Therapeutics has been manufacturing sterile kits to be used in ophthalmic surgery.

While the drug has only been on the market since July 2012, its inception began six years ago by Ed Timm, the president of Mobius Therapeutics.  According to the St. Louis Business Journal, Mr. Timm moved the company’s manufacturing operations to St. Louis, giving his company access to “the cluster of medical device and drug discovery companies.”  Mobius was initially funded through a variety of sources, and it has received funding from sources that include a $50,000 prize from the St. Louis County Economic Council business plan competition, a $240,000 grant from Obama’s stimulus program, and a $150,000 investment from the BioGenerator life sciences seed fund.

When Mitosol received FDA approval, Timm described the product’s approval as “the culmination of six years of collaborative work with the FDA and clinicians.”  The company has since been manufacturing the sterile vials and procedure kits for use in the surgical treatment of glaucoma.  Mitosol was the first Mobius product to go on the market.

What You Need to Know About the Recall

The FDA indicates that the recall affects twenty states in which the product was distributed.  Currently, Mobius has not received any reports of injuries from use of these lots of Mitosol.  The American Society of Health-System Pharmacists reported that all affected customers have been informed about the recall.  In fact, Timm indicated that all customers who purchased the non-sterile product have been contacted through personal phone calls.  He emphasized that the recall notice was a failsafe measure intended to ensure that notification reached everybody who may have been affected by the non-sterile lots.

The recalled product shipped originally between October 22 and December 14, 2012, and its lot numbers are M098260 and M086920.  If you have the affected product in your possession, the FDA indicates that you should stop using the product immediately and contact Mobius directly at 1-877-393-6484 in order to safely return the medication.  You should also report any injuries from product use to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.  If you or a loved one have been adversely affected by the Mitosol recall, an experienced attorney can discuss your options with you.  Contact us today.

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