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Sterile Prescriptions Recalled after FDA Finds Companys Clean Room Contaminated

Wed, 6 Jun 2012 10:55:39 EST

The Food and Drug Administration (FDA) detected the presence of microorganisms in the clean room of Franck's Compounding Lab, which has initiated a recall of all sterile human and veterinary prescription products that it distributed.
 
The recall applies to all sterile preparations from the Florida-based company since November 21, 2011.
 
The compounding laboratory has faced issues with the sterility and chemical composition of their products in the past.
 
Earlier this year, health officials reported that tainted preparations caused 33 rare fungal eye infections in patients who had undergone eye surgery. While investigating, the FDA discovered numerous fungal and bacterial species in unopened products at the compounding pharmacy.
 
In 2009, the authorities faulted Franck's after 21 polo horses died before a championship match in West Palm Beach. On the orders of the team's veterinarian, they had been given vitamins and minerals by the pharmacy, which accidentally put a fatal dose of selenium into the cocktail.
 
The company states in a press release that the recall should be carried out at the physician level and asks that doctors review patient records to determine if any adverse events possibly resulted from use of the contaminated products. Any problems associated with the use of Frank's prescriptions should be reported to the company and the FDA's MedWatch program.