Franck's issues urgent prescription recall
Franck’s Pharmacy is issuing an urgent recall of all its sterile veterinary and human prescriptions distributed between Nov. 2011 and May 2012.
The recall was prompted after a Food and Drug Administration (FDA) inspection revealed the presence of microorganisms and fungal growth at the facility.
"In light of the FDA’s findings and the resulting possible risk of infection, we have decided that it is imperative that we recall all human and veterinary sterile preparations that have left our control," Franck’s said in a news release.
The recall affects any and all sterile veterinary and human prescriptions distributed by the Florida-based Franck’s from Nov. 21, 2011 to May 21, 2012.
"If any of these sterile preparations remains under your control, it is essential that you do not use them and that employing appropriate practices, you destroy all such sterile preparations and all remaining portions of such sterile preparations," Franck’s told its consumers in a news release.
Franck’s says the recall should be carried out to the user/physician level, and that physicians should review and evaluate their patient records to determine if adverse events may have resulted from use of any of the recalled products. Consumers of Franck’s products are asked to read, complete, and return a response form as soon as possible.
"FDA will expect us to be able to account for all of the sterile preparations subject to this recall," Franck’s said. "We will update you with any relevant details as they become available to us."
According to a local newspaper in Ocala, Fla., Franck’s announced May 23, 2012 that it would stop its sterile compounding services. It also announced the layoffs of several employees.
According to the Centers for Disease Control (CDC), the California Department of Public Health was notified in March 2012 of nine human cases of clinically diagnosed fungal endophthalmitis at a single California ambulatory surgical center. Endophthalmitis is an inflammation of the internal coats of the eye.
The investigation determined that in all cases patients had used a dye called Brilliant Blue-G (BBG) from Franck's Compounding Lab. The investigation expanded to involve injections into the eye of triamcinolone-containing products from Franck's, an overall total of 33 cases in seven states. In early May, the CDC warned clinicians that they should be aware of the ongoing investigation and avoid use of compounded products labeled as sterile from Franck's.
In 2010, the FDA sought a permanent injunction against veterinary compounding facility Franck’s Lab, Inc., alleging that the use of active pharmaceutical ingredients in compounding veterinary preparations for non-food producing animals was illegal.
In September 2011, a Florida District Court ruled that Congress did not give the FDA the ability to take enforcement action against a pharmacy engaged in the traditional practice of compounding. The court also ruled that the FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy so long as the pharmacy’s activities are not manufacturing.
The FDA has since appealed that ruling.
Franck’s made headlines in 2009, when 21 polo horses from the Lechuza Caracas polo team died at the U.S. Open Polo Championships after they were given a compounded formula of Biodyl. Franck’s, the pharmacy that prepared the formula, admitted shortly after the incident that it had made an error and had incorrectly prepared the formula.
Consumers with questions can call Franck’s at 352-690-6773, Monday through Friday from 9 a.m. to 5 p.m., EST.
For more information about the recall, visit the posted notice on the FDA website.