The FDA is advising healthcare professionals and consumers against the use of drugs marketed as sterile by Downing Labs LLC, also known as NuVision Pharmacy in Dallas, TX, as they may be contaminated.
The FDA inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company. The inspection revealed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in three lots of drug products, and inadequate or no investigation of these failures.
Administration of non-sterile drug products intended to be sterile may result in serious and potentially life-threatening infections or death. Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients.
For more information visit the FDA Safety Alert page.