The US Food and Drug Administration 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, healthcare providers should stop using all sterile products distributed by CSCP and return them to the company.
The Centers for Disease Control and Prevention 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,” said 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.
Patients who have received any product distributed by CSCP and have concerns should contact their healthcare provider. The FDA asks healthcare professionals and consumers to report any adverse reactions to the FDA’s MedWatch program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
Healthcare providers with questions may contact CSCP at 866-880-1915, Monday through Friday, between 10 a.m. and 5 p.m. eastern time.
Lucentis (ranibizumab injection) and Eylea (aflibercept) are approved by the FDA for the treatment of wet age-related macular degeneration. Avastin is not approved by the FDA for this purpose. Avastin is approved for other indications.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.