The U.S. Food and Drug Administration is notifying health care professionals and consumers about safety concerns with all sterile-use drug products made and distributed by Downing Labs LLC, doing business as NuVision Pharmacy, in Dallas Texas. Because NuVision Pharmacy is licensed in Rhode Island as a non-resident compounding pharmacy, the Rhode Island Department of Health is alerting physicians and patients who may have received a product from Downing Labs LLC or NuVision Pharmacy that these medications should not be taken.
"We are exercising due diligence in respect to NuVision/Downing Labs. We are unaware of any immediate threat to Rhode Islanders but people should be aware if they have medication from NuVision/Downing Labs," said Michael Fine, MD, Director of the Rhode Island Department of Health. "NuVision Pharmacy has assured us that they will not ship any medication to Rhode Island until the issue is resolved with the FDA and that they have not shipped into Rhode Island since before January 2014."
Until further notice, health care professionals should not prescribe, administer or dispense any NuVision/Downing Labs sterile products for their patients because the firm cannot ensure the safety or quality of these products. Administration of a non-sterile drug product may result in serious and potentially life-threatening infection or death.
The FDA has issued a formal request to Downing Labs for the immediate recall of all lots of its purportedly sterile products currently on the market that are not expired. In the letter, the FDA outlined poor conditions and practices identified by FDA investigators during a July 2014 inspection of Downing Labs' Dallas facility. In the letter, the FDA outlined the practices and facility conditions that raise concerns about the sterility assurance of purportedly sterile drug products made at the Downing Labs facility.
"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, M.D., 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."
The FDA's recent inspection of the Downing Labs facility in Texas 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, and changes in blood pressure and in other circulatory functions.
On July 18, 2014, the FDA alerted health care professionals not to use purportedly sterile drugs from NuVision/Downing Labs due to possible contamination. On July 26, 2013, after observing poor conditions and practices during a March – April 2013 inspection, the FDA formally requested NuVision Pharmacy recall all sterile use drug products. The FDA reminds health care professionals to check their medical supplies, and quarantine any purportedly sterile drug products prepared at the Downing Labs/NuVision's facility, and not administer them to patients.
Products made at the Downing Labs facility are distributed nationwide. Most of the product labels include: NuVision Pharmacy, Dallas Texas 75244. 1-800-914-7435. Patients who have received any drug product produced at the Downing Labs/NuVision facility and have concerns should contact their health care professional and may contact the Rhode Island Department of Health at (401)-222-5960.
The FDA is not aware of recent reports of illness associated with the use of these products. The FDA asks health care providers and consumers to report adverse reactions or quality problems experienced with the use of any products made at the Downing Labs facility to the FDA's MedWatch Adverse Event Reporting program by: · completing and submitting the report online at www.fda.gov/medwatch/report.htm; or · downloading and completing the form, then submitting it via fax to 1-800-FDA-0178.