Georgia Compounding Pharmacy Recalls All Sterile Products After Eye Infections Reported

Topics: Compounding

FDA is alerting health care providers and patients of a voluntary recall of all sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, GA. This expanded recall was initiated  for all of the pharmacy’s sterile products that were distributed nationwide between October 19, 2012 and March 19, 2013. The recall was prompted after FDA inspections revealed practices at the pharmacy that raised concerns about a lack of sterility assurance. Additionally, five patients were reported to have been diagnosed with endophthalmitis, an inner-eye infection that can lead to permanent vision loss, after they received intravitreal injections with Avastin® (bevacizumab) that were repackaged by CSCP into individual, single-use syringes. FDA asks that health care providers report any adverse events to the FDA MedWatch program. FDA advises that patients who have received any product distributed by CSCP and have concerns should contact their health care provider.