The Food and Drug Administration (FDA)Â 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 FDAs 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.
CSCPs 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.
Â
The Centers for Disease Control and Prevention (CDC)Â 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.
Â
A compromised sterile product puts patients at risk for serious infections, says Janet Woodcock, MD, director, FDAs 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.
Â
The FDA continues to work with the CDC and state health departments to determine the scope of any contamination.
Â
Source: FDA
Beyond the Surface: Rethinking Environmental Hygiene Validation at Exchange25
June 30th 2025Environmental hygiene is about more than just shiny surfaces. At Exchange25, infection prevention experts urged the field to look deeper, rethink blame, and validate cleaning efforts across the entire care environment, not just EVS tasks.
A Controversial Reboot: New Vaccine Panel Faces Scrutiny, Support, and Sharp Divides
June 26th 2025As the newly appointed Advisory Committee on Immunization Practices (ACIP) met for the first time under sweeping changes by HHS Secretary Robert F. Kennedy Jr, the national spotlight turned to the panel’s legitimacy, vaccine guidance, and whether science or ideology would steer public health policy in a polarized era.
Getting Down and Dirty With PPE: Presentations at HSPA by Jill Holdsworth and Katie Belski
June 26th 2025In the heart of the hospital, decontamination technicians tackle one of health care’s dirtiest—and most vital—jobs. At HSPA 2025, 6 packed workshops led by experts Jill Holdsworth and Katie Belski spotlighted the crucial, often-overlooked art of PPE removal. The message was clear: proper doffing saves lives, starting with your own.