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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

If you need an attorney to represent you, we invite you to consider Terrell ● Hogan. For a free consul­tation, call (904) 722‑2228  or 1–888-244‑5557 (toll free).