March 21, 2013 at 12:56 PM ET
A Georgia compounding pharmacy that recalled eye injections earlier this week because of possible contamination is recalling everything it made now.
The Food and Drug Administration says Clinical Specialties of Augusta, Ga., is voluntarily recalling all lots of all sterile products it repackaged and distributed because it cannot assure they are sterile. The agency has cracked down on compounding pharmacies after an outbreak of fungal meningitis and other fungal infections that has affected 722 people and killed 50.
“This expanded recall follows the firm’s initial recall of Avastin on March 18, 2013, due to reports of five patients who have been diagnosed with serious eye infections associated with the use of the product,” the FDA said in a statement.
“The Centers for Disease Control and Prevention (CDC) notified the FDA of these endophthalmitis infections, which occur inside the eyeball. Endophthalmitis after intravitreal injection is a serious complication that can lead to permanent loss of vision. Clinical Specialties Compounding sterile products covered under this recall were distributed nationwide between October 19, 2012 and March 19, 2013.”
The firm was repackaging the cancer drug Avastin for use in treating a degenerative eye condition called macular degeneration. The drug has been shown to help stop progression of the disease.
The drug company Roche, which makes Avastin, makes a version called Lucentis specifically for use in the eye. But Lucentis costs as much as $2,000 per dose, compared to $150 a dose for Avastin when reformulated by a compounding pharmacist. Roche has complained that repackaging Avastin in this way can lead to contamination and infections.
The FDA says Clinical Specialties isn’t able to ensure that its practices are keeping its products sterile. Inspections at the New England Compounding Center, which caused the fungal meningitis outbreak, showed widespread contamination and poor hygiene.
“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 says.