The U.S. Food and Drug Administration (FDA) has safety concerns about sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas.
An FDA press release states, "Health care professionals should not use any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products."
FDA says it is not aware of recent reports of illness associated with the use of these products and asks health care professionals to report adverse reactions or quality problems with any products made at the Downing Labs facility to the FDA's MedWatch Adverse Event Reporting program.
The agency issued a formal request to Downing Labs in September for the immediate recall of all of its purportedly sterile products currently on the market. In the letter, FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs' Dallas facility. 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.
"Patient safety is our top priority. We recommend health care professionals stop prescribing sterile drugs from Downing Labs because they pose serious potential risks to patients," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research. "Patients deserve medications that are safe, effective, and of high quality no matter who makes them, and the FDA will continue to take action to protect patients."
Action, Oct. 31, 2014
Last Updated On
May 12, 2016