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FDA: Compounding centerís products may be tainted

Monday March 25, 2013
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The Food and Drug Administration has alerted healthcare providers and patients of a voluntary recall of all lots of sterile products produced and distributed by Clinical Specialties Compounding Pharmacy of Augusta, Ga.

The recall of all sterile products is due to the FDAís preliminary findings of practices at the site that raise concerns about a lack of sterility assurance. The expanded recall comes after reports of five patients who have been diagnosed with endophthalmitis infections associated with use of Avastin (bevacizumab) repackaged into syringes by CSCP.

CSCPís sterile products covered under this expanded recall were distributed nationwide between Oct. 19, 2012, and March 19, 2013. Until further notice, healthcare providers should stop using all sterile products distributed by CSCP and return them to the company.

The Centers for Disease Control and Prevention notified the FDA of the endophthalmitis infections, potentially serious complications that can lead to permanent loss of vision. CSCP repackaged the Avastin into individual single-use syringes from manufactured vials labeled as sterile.

"A compromised sterile product puts patients at risk for serious infections," Janet Woodcock, MD, director of the FDAís Center for Drug Evaluation and Research, said in a news release. "Healthcare professionals should ensure that any medicines they administer to patients are obtained from appropriate, reliable sources and are properly administered."

The FDA continues to work with the CDC and state health departments to determine the scope of any contamination. Note that Avastin has not been approved by the FDA for the treatment of wet age-related macular degeneration, although it is approved for other indications. Lucentis (ranibizumab injection) and Eylea (aflibercept) are approved for this purpose.

Healthcare providers with questions may contact CSCP at 866-880-1915, Monday through Friday, between 10 a.m. and 5 p.m. ET. For more information, including lot numbers affected by the recall, see www.fda.gov/Safety/Recalls/ucm344377.htm.

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