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Franck’s Lab Product Suspected of Causing Eye Infections

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According to a report from the Centers for Disease Control and Prevention recently issued,  doctors should not  use any sterile products produced by Ocala Florida’s Franck’s Compounding Lab after two eye products made by the company are suspected in causing at least 33 cases of fungal eye infections.

Franck’s has issued recalls of the products.  But because the CDC said the root cause of the contamination was not known and the infections have been so serious causing vision loss, the federal agency issued the warning to avoid any product labeled sterile from Franck’s.

Although the investigation is ongoing, Franck’s continues to compound sterile products.

It is not the first time Frank’s products have been alleged to harm those they were meant to help.  In 2009, Franck’s  improperly mixed a supplement for 21 polo horses that contained far more selenium than required. The horses all died.

In March the California Department of Public Health was notified of nine cases of fungal eye infections from one surgical center.  All  involved patients who had undergone eye surgery and to whom the Franck’s-produced Brilliant Blue-G dye was administered. Almost immediately,  Franck’s recalled all of its Brilliant Blue-G dye, according to its website.  The dye is used by surgeons to highlight internal features of the eye during surgery.

More cases were discovered and included products containing the corticosteroid triamcinolone acetonide.  On March 29, Franck’s also recalled two lots of that preparation. The company website said the recall affected nine physicians and 13 prescriptions, and all the product was identified.

CDC tests confirmed the presence of several bacterial and fungal contaminants in sealed bottles and syringes of the dye.

The fungi that caused the infections are common, but the type of infections seen in the outbreak are very rare. Once introduced into the eye fluid, the fungi blooms and causes infection which can damage vision.

Of the 33 cases identified, 23 of the patients suffered partial to severe vision loss and 24 required additional eye surgery, according to the CDC report.

Contact our experienced personal injury and products liability attorneys if you would like to discuss your potential claims for injury resulting from a defective product.

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