The Food and Drug Administration (FDA) is warning healthcare professionals and consumers again about all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas, TX.
The FDA has requested Downing Labs to immediately recall all lots of its unexpired sterile products currently on the market because the safety or quality of these products cannot be ensured. A recent inspection of the facility showed sterility failures in 19 lots of drug products intended to be sterile, endotoxin failures in 3 lots of drug products, and inadequate or no investigation of these failures. The FDA previously alerted healthcare professionals to not use sterile drugs from NuVision/Downing Labs on July 18, 2014.
Administration of a non-sterile drug product can result in potentially fatal infections or death. The FDA urges healthcare professionals to check medical supplies and quarantine any intended sterile drug products prepared at the Downing Lab facility.
For more information call (800) 914-7435 or visit FDA.gov.