Published March 22, 2013
The U.S. Food and Drug Administration is alerting health care providers that a Georgia compounding pharmacy has recalled all of its sterile products distributed in the United States since October 19, following reports of serious eye infections, the agency said on Thursday.
Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company, the FDA said.
The FDA had previously reported the five cases of serious eye infection from injections of the cancer drug Avastin, which was prepared by Clinical Specialties Compounding Pharmacy (CSCP) to treat the eyesight robbing disease macular degeneration. The drug is not approved for that use, but when cut into doses appropriate for the eye it is substantially cheaper than similar drugs approved for the eye condition.
The voluntary recall was expanded beyond Avastin to include all of CSCP's sterile products after the FDA's preliminary findings at the manufacturing site in Augusta, Georgia, raised concerns about a lack of sterility assurance, the agency said.
The recall includes dozens of drugs, including antibiotics and numerous eye drugs.
"A compromised sterile product puts patients at risk for serious infections," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"Health care professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered," she added.
Compounding pharmacies, which alter or combine drugs to meet special needs of patients or prepare drugs for unapproved uses, such as with Avastin, have come under increased scrutiny since tainted injectable steroids manufactured by a Massachusetts compounder led to a meningitis outbreak last year that caused more than 40 deaths and injured hundreds of patients.
The FDA said it was working with the U.S. Centers for Disease Control and Prevention and with state health departments to determine the scope of any contamination caused by products from the Georgia pharmacy.