EDITORS' NOTE: This story was updated May 24, 2012, 7:20 p.m. EDT, to include information about the company’s termination of its sterile compounding business.
Franck’s Compounding Pharmacy recalled all sterile compounds it distributed between Nov. 21, 2011, and May 21, 2012, and permanently ceased production of sterile compounds, the Ocala, Fla.-based company reported today.
The pharmacy issued the recall after a U.S. Food and Drug Administration environmental sampling revealed the presence of microorganisms and fungal growth in the pharmacy’s clean room. Patients taking sterile prescriptions prepared by Franck’s during the six month window are at risk of infection, the company said.
The company advised veterinarians and physicians in possession of sterile prescriptions distributed during the six-month window to destroy the preparations using appropriate practices. They should also review patient records to determine any adverse events that may have resulted from the use of the recalled products and report the events to Franck’s and the FDA’s MedWatch program.