May 29, 2012
Franck's recall triggered by rash of fungal eye infections
Pharmacy's ophthalmic drops, parenteral medications included
By: Jennifer Fiala
For The VIN News Service
The recall of six months worth of sterile compounded preparations from Franck's Pharmacy — preparations intended for veterinary and human medicine — was prompted, in part, by cases of a rare fungal eye infection reported to the Centers for Disease Control and Prevention (CDC).
It's unclear how many orders for compounded medications Franck's has filled since last fall, but if customers purchased a sterile preparation from Franck's between Nov. 21, 2011 and May 21, 2012, the U.S. Food and Drug Administration (FDA) advises against using it. In response to contamination concerns, Franck's wants users to "destroy all such sterile preparations and all remaining portions of such sterile preparations."
For veterinarians and pet owners, the recall includes eye drops and injectables sold by Franck's, which likely would have been prepared in the clean room where the FDA reportedly found microorganisms and fungal growth following an environmental sampling of the facility.
The FDA is working in cooperation with the CDC to identify contaminants and quell the spread of fungal infections.
According to the compounding pharmacy's website, non-sterile compounded medications such as suspensions and capsules as well as prescriptions from Franck's Home Infusion Pharmacy are not included in the recall.
Franck's announced last Wednesday that it will cease producing sterile compounds at its Ocala, Fla.-based lab. Company representatives did not return a call from the VIN News Service. A call to the Franck's recall hotline was picked up by voice mail.
An introductory message said of the recall: "All affected parties will receive notification by U.S. mail along with a response card that needs to be filled out and returned." The recording did not elaborate, but Franck's noted on its website that: "FDA will expect us to be able to account for all of the sterile preparations subject to this recall. As a result, it is critically important that you read, complete, and return the enclosed response form as soon as possible."
On May 4, The CDC reported that between November 2011 and April 30, 33 people across seven states contracted fungal endophthalmitis, many of them suffering vision loss and requiring surgery. The CDC linked the cases to a contaminated batch of Franck's Brilliant Blue G, or BBG, an injectable dye that contains triamcinolone and is used by ophthalmologists during eye surgeries.
Franck's is a major provider of compounded medications to veterinarians and pet owners. It's known for serving the equine industry, making unique injectable formulations for horses.
In April 2009, one such formulation — an injectable supplement — caused the death of 21 polo horses just before a U.S. Open Polo Championships match in West Palm Beach, Fla. Almost immediately, Franck’s admitted that the supplement had been mixed improperly.
Since then, the company has been the focus of legal attempts by the FDA to cement its jurisdictional authority over compounded medications for veterinary medicine. Last September, Franck's won a lawsuit brought by regulators that intended to shut down the compounding pharmacy. At the time, 40 percent of the company’s total sales were comprised of animal medications and Franck's filled roughly 37,000 prescriptions for animals annually.
The U.S. Department of Justice is appealing the decision.
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