[7/18/2014] The U.S. Food and Drug Administration is alerting health care professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated.
Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.
NuVision’s products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435
FDA investigators inspected NuVision and observed insanitary conditions that result in a lack of sterility assurance of purportedly sterile drug products produced by the company, which puts patients at risk (Form FDA-483 issued July 16, 2014). 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. Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions such as fever, shock, changes in blood pressure, and in other circulatory functions.
Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.
FDA is not aware of recent reports of illness associated with the use of these products. FDA asks health care professionals and consumers to report adverse events or quality problems associated with the use of NuVision’s products to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178
For more information:
- FDA press release, April 15, 2013: FDA issues alert about lack of sterility assurance of drug products from ApotheCure, Inc. and NuVision Pharmacy and of forthcoming recall
- FDA Form 483 issued April 16, 2013
- FDA press release, May 18, 2013: FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
- FDA recall request, July 26, 2013
- FDA press release, Aug. 16, 2013: FDA reminds health care providers not to use sterile products from NuVision Pharmacy