[Posted 07/19/2014]

AUDIENCE: Risk Manager, Health Professionals, Pharmacy, Consumer

ISSUE: FDA 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. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

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.

BACKGROUND: NuVisions products were distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas TX. 75244 1-800-914-7435.

RECOMMENDATION: Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/18/2014 - Drug Alert - FDA]