According to the U.S. Food and Drug Administration (FDA), Clinical Specialties of Augusta, Georgia is voluntarily recalling all sterile products that it has repackaged and distributed. The recall was prompted by the diagnosis of serious eye infection in five patients who used one of the defective products.
On March 18, 2013, Clinical Specialties recalled lots of Avastin following multiple cases of endophthalmitis infection. Endophthalmitis is a very serious infection that can lead to permanent vision loss. Products affected by this recall were distributed nationwide between October 19, 2012 and March 19, 2013.
Clinical Specialties repackaged Avastin–a cancer drug–to be used in the treatment of macular degeneration, a degenerative eye disease that has been shown to respond to Avastin. Roche laboratories, the manufacturer of Avastin, also manufactures a version of the drug under the name of Lucentis. Lucentis is specifically for use in the eye. Lucentis costs as much as $2,000 for one dose, in comparison to one dose of repackaged Avastin at a cost of $150. Roche has complained that repackaging Avastin by the compounding company could result in contamination leading to infection and disease.
The FDA states that Clinical Specialties is not able to guarantee that its products are sterile. “Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and return them to the company,” said the FDA.
The FDA had “cracked down” on compounding pharmacies following a widespread outbreak of fungal meningitis that killed 50 people and injured another 722. That outbreak was caused by contamination of products at the New England Compounding Center.
For more information, contact the Ohio defective product lawyers at Clark, Perdue & List.
Source: NBC News, “Georgia pharmacy expands recall after eye infections,” Maggie Fox, March 20, 2013.