October 21, 2015 — After years of concern about sterility, Downing Labs LLC has issued a recall for compounded drugs that may not be sterile.
Downing Labs is a compounding pharmacy that sold custom-made drugs nationwide and in the UK. The recall was issued after FDA inspections two weeks ago found evidence of unsanitary conditions, according to Dallas News. According to the report:
“A variety of spore forming bacteria are routinely recovered from your environmental and personnel monitoring within the aseptic processing areas.”
Last year, Downing Labs co-owner Ashley Downing took the unusual move of refusing to issue a recall after FDA inspectors found “sterility failures in 19 lots of drug products.” In September 2014, the FDA warned that the drugs “pose serious risk to patients” and should not be used.
Downing worked for two other compounding pharmacies in the same location that have been shut down over sterility concerns. One of those pharmacies, NuVision, was purchased by Downing Labs. NuVision also rejecting recall requests from the FDA. The other pharmacy, ApotheCure, pled guilty to criminal charges with the Justice Department after tainted drugs caused three deaths.
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