March 22, 2013
A Georgia compounding pharmacy on Thursday recalled all of its sterile products because of Food and Drug Administration (FDA) concerns about safety.
This is the second compounding pharmacy to recall products this week. Compounding pharmacies have been in the spotlight since September, after a nationwide outbreak of fungal meningitis caused by contaminated steroid injections distributed by the Massachusetts-based New England Compounding Center.
The newest recall comes from Clinical Specialties Compounding Pharmacy of Augusta, GA, which on Monday recalled shipments of the drug Avastin, used to treat macular degeneration, a common cause of age-related blindness. Five patients have reported serious eye infections linked to vials of Avastin, which the pharmacy had repackaged into single-use syringes, from manufactured vials labeled as sterile. On Thursday, the company expanded that recall to include all of its sterile products, not just Avastin.
On Monday, New Jersey-based Med Prep Consulting recalled all products compounded at its facility after mold was found in bags of magnesium sulfate.
Critics of the compounding industry say they aren't surprised by the continued recalls.
Michael Carome, a physician and deputy director of Public Citizen's Health Research Group, says compounding pharmacies have expanded beyond their traditional role of mixing prescriptions for individual patients to become, in many cases, large-scale manufacturers.
Carome says the recalls stem from "at least a decade of inadequate enforcement by the FDA."
The recalled products from the Georgia pharmacy were distributed between Oct. 19, 2012, and March 19, 2013. FDA officials say doctors should stop using all sterile products from this company until further notice.
The eye infections, called endophthalmitis, can lead to permanent loss of sight.
"A compromised sterile product puts patients at risk for serious infections," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, 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."
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