September 9, 2013 — Avella Specialty Pharmacy has issued a voluntary recall for two compounded medications because they may not be sterile. The recalled medications include Avastin (bevacizumab), which is commonly compounded into smaller vials for the treatment of macular degeneration, and vancomycin, an antibiotic. No adverse events have been reported.
The recall was initiated after the U.S. Food and Drug Administration (FDA) found problems during an inspection of Front Range Laboratories, which is Avella Specialty Pharmacy’s independent third-party testing laboratory. Avella has discontinued its relationship with Front Range Laboratories as a result of the problem.
According to the FDA:
“FDA investigators observed methods used to assess sterility and other qualities (e.g. strength and stability) which may have resulted in Avella receiving inaccurate laboratory test results on the specified lots. FDA has raised concerns that test results obtained from Front Range Labs may not be reliable.”
|Bevacizumab 1.25 mg/0.05 mL PF||12-20130508@179||11/3/2013|
|Vancomycin PF (BSS) 1%||12-20130508@181||10/4/2013|
The FDA also warned that patients who are treated with the medications can develop a life-threatening infection. In 2013, the FDA has stepped up its regulatory actions on compounding pharmacies considerably, issuing dozens of warning letters and recalls. The increased enforcement action is a result of an outbreak of fungal meningitis last year that injured more than 750 people and killed 63.
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