The Food and Drug Administration (FDA) is alerting healthcare providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, Ga. The recall of all sterile products is due to the FDA’s preliminary findings of practices at the site which raise concerns about a lack of sterility assurance. This expanded recall comes after reports of five patients who have been diagnosed with serious eye infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.
CSCP’s sterile products covered under this expanded recall were distributed nationwide between Oct. 19, 2012, and March 19, 2013. Until further notice, health care providers should stop using all sterile products distributed by CSCP and return them to the company.
The Centers for Disease Control and Prevention (CDC) notified the FDA of these infections, called endophthalmitis, which occurs inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. CSCP repackaged the Avastin into individual single-use syringes from manufactured vials labeled as sterile.
“A compromised sterile product puts patients at risk for serious infections,” says Janet Woodcock, MD, director, FDA’s Center for Drug Evaluation and Research. “Healthcare professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered.”
The FDA continues to work with the CDC and state health departments to determine the scope of any contamination.