Clinical Specialties Compounding Pharmacy issued a recall Wednesday of vials of Avastin after reports of five patients in Georgia becoming infected after eye injections. The recall was widened Thursday to all sterile products produced by the pharmacy since Oct. 19, according to the FDA.
The FDA said the wider recall is because of “preliminary findings of practices at the site which raise concerns about a lack of sterility assurance.” Pharmacy owner Austin Gore said he did not know what the FDA was referring to because he got a report Wednesday that no contamination had been found and that the lone cases of infection were at a single doctor’s office.
Clinical Specialties, which has been creating custom drug products for doctors since 2005, has not changed its sterile techniques, Gore said, and the hood where the compounding is performed tested negative for contamination.
Avastin is a cancer drug, but for years, eye surgeons have been using it “off-label” to treat a form of macular degeneration that can lead to vision loss. Doctors ship a vial of Avastin to Clinical Specialties, which breaks it down into the much smaller doses needed to treat eye problems, Gore said.
He called the process a “sterile-to-sterile draw” and estimated the company had done about “150,000 of these unit-dose draws without incident.”
Clinical Specialties had been working with about a dozen physicians on the Avastin doses, Gore said. In November, a new physician in Georgia, who Gore said was not in Augusta but otherwise did not identify, began using its services and sent a vial of Avastin to the pharmacy Feb. 13 to be broken into doses. That physician is the one who reported the five eye infections, Gore said.
The FDA identified the infection as endophthalmitis, which can lead to permanent loss of vision.
There are a few places where contamination could occur, Gore said: in the original vial; through the compounding process; or in the physician’s office.
“We have not changed our procedure since 2005,” Gore said. “We don’t have any concerns about the Avastin vial. This was an isolated incident
to this particular doctor’s office.”
When asked whether the FDA asked the pharmacy to widen the recall, Gore said, “That would be correct.” Asked whether the FDA was there now, he said, “That would be correct.”
Late Thursday, the FDA said it was working with the Centers for Disease Control and Prevention and state health departments “to determine the scope of any contamination.” Gore said he had not heard of any
problems outside that one office.