October 21, 2015 — Downing Labs, LLC, a Dallas-area compounding pharmacy, has issued a recall because their products may not be sterile.
The recall was issued for all lots of sterile products distributed nationwide and in the U.K. from April 20 to September 15, 2015.
Dallas News reports that the FDA found sterility issues at Downing Labs during an inspection two weeks ago:
“A variety of spore forming bacteria are routinely recovered from your environmental and personnel monitoring within the aseptic processing areas.”
The FDA also found “sterility failures in 19 lots of drug products” after an inspection last year. Ashley Downing, co-owner of Downing Labs, refused to issue a recall, so the FDA warned consumers not to use the products because they “pose serious risk to patients.”
Ms. Downing worked for two compounding pharmacies at the same location in Dallas that have been shut down. One company, ApotheCure, was sued by the Justice Department after causing three deaths. The other pharmacy, NuVision, was purchased by Downing Labs. NuVision repeatedly rejected requests by the FDA to recall products.
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