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Recently, a Massachusetts pharmaceutical compounding company was linked to a steroid product that was tainted with meningitis, resulting in the deaths of over 20 patients. For the second time in a few years, an Ocala pharmaceutical compounding company has been charged with issuing tainted products. In March 2012, the Centers for Disease Control and Prevention issued a report warning doctors across the country not to use any sterile products produced by Ocala’s Franck’s Compounding Lab.

Franck’s Brilliant Blue-G dye has been linked to more than 30 cases of fungal eye infections. The dye is used by ophthalmic surgeons to highlight internal features of the eye during eye surgery. That dye is not approved by the Food and Drug Administration for use in the United States. Patients who were exposed to Franck’s dye and suffered fungal eye infections have experienced severe vision loss and many required additional eye surgery.

Compounding pharmacies, like Franck’s, combine or alter medication from standard preparations and provide needed formulations that are often not available from pharmaceutical companies. Compound sterile preparations must be prepared according to aseptic practices. However, contamination of compounded sterile preparations has caused outbreaks. Since 1990, the Food and Drug Administration has learned of approximately 200 adverse events associated with 71 different compounded products.

In 2009, Franck’s veterinary division faced charges of improper compounding when it mixed a nutritional supplement for 21 polo horses at an international polo event in West Palm Beach. All 21 horses died as a result of ingesting the tainted compound.

The investigation into how the fungus contaminated the Brilliant Blue-G dye continues. While Franck’s has recalled the product, the CDC says the root cause of the contamination is not known. Because of this and the seriousness of the infections that have caused vision loss, the federal agency issued a warning to avoid any product labeled as sterile from Franck’s.

Franck’s continues to compound sterile products, including products used during chemotherapy and spinal surgery, according to the CDC.

FDA Report: Franck’s Compounding Pharmacy Sterile Preparations: Reports of Fungal Endophthalmitis, Expanded Recall

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