Credit: Bill Branson
The US Food and Drug Administration (FDA) is alerting healthcare professionals and consumers not to use sterile drugs produced by Downing Labs LLC, also known as NuVision Pharmacy, as the products may be contaminated.
Healthcare professionals should immediately check their medical supplies and quarantine any sterile products from NuVision.
Administration of a non-sterile drug product may result in serious and potentially life-threatening infections or death.
NuVision’s products were distributed nationwide. Most of the product labels say, “NuVision Pharmacy, Dallas TX, 75244 1-800-914-7435.”
FDA investigators inspected NuVision and observed unsanitary conditions that result in a lack of sterility assurance of purportedly sterile products, which puts patients at risk.
The inspection revealed sterility failures in 19 lots of products intended to be sterile, endotoxin failures in 3 lots of products, and inadequate or no investigation of these failures. Endotoxins are substances found in certain bacteria that cause a variety of serious reactions such as fever, shock, and changes in blood pressure and other circulatory functions.
The FDA is not aware of recent reports of illness associated with the use of these products.
Patients who have received any product produced by NuVision and have concerns should contact their healthcare professional.
Healthcare professionals and consumers can report adverse events associated with the use of NuVision’s products to the FDA’s MedWatch Adverse Event Reporting Program.
