The FDA is notifying all physicians and healthcare organizations of the recall of all sterile products sold by Franck’s Compounding Pharmacy since November 2011 due to the possibility of lack of sterility.
In March 19, 2012, FDA received reports of fungal endophthalmitis in patients who were given Brilliant Blue G (BBG), supplied by Franck’s Pharmacy, during eye surgeries. In April 20, 2012, FDA received reports of eye infections in patients who were given injections of Franck’s drug products containing triamcinolone acetonide during eye surgery.
An active investigation by the CDC and FDA is ongoing at this time. FDA advises that any product received from Franck’s since November 2011 not be used.
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm.