There are currently over 30 product liability lawsuits pending against Franck’s Compounding Lab in Ocala, Florida. Plaintiffs, all of whom have suffered fungal endophthalmitis (serious eye infections), blindness, or even loss of one or two eyes, are suing Franck’s for negligence and failure to warn against the side effects of their product. Franck’s Brilliant Blue G Surgical Dye (BBG), the culprit behind the mass infections and other symptoms, was never approved by the FDA for use in the United States.
Endophthalmitis is a fungal eye infection marked by inflammation, and is typically treated by an intravitreal injection, or an injection straight into the eye. If left untreated, endophthalmitis can result in blindness, or the loss of the eye itself.
BBG, manufactured by Franck’s Pharmacy, has been reported to cause fungal endophthalmitis (fungal eye infections) in patients who were injected with the drug during eye surgeries. BBG is not approved for use in the United States, but has been used in eye surgeries nonetheless.
On March 19, 2012, Franck’s Compounding Lab issued a recall of all BBG, and the FDA issued a warning against this drug. In its initial warning, the FDA stated that multiple practitioners across the country have noted adverse side effects associated with BBG, and should immediately report any further cases of fungal endophthalmitis.
In May, 2012, the FDA issued a recall on all Franck’s products. According to the FDA website, investigators had found microogranisms and fungal growth in their sterile environments. By the time of this second recall, over 30 lawsuits had been filed against the pharmaceutical company by past patients alleging that they had been exposed to fungal endophthalmitis.
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