Events

Safety Alert for Sterile Products

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by NuVision Pharmacy.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-19
  • Event Date Posted
    2013-08-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130819.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: sterile products from nuvision pharmacy the united states food and drug administration (fda) has issued a press release to remind health care providers about safety concerns with all sterile drug products made and distributed by nuvision pharmacy of dallas, texas. the fda advises that health care providers should not administer any nuvision pharmacy sterile products to patients because the products’ sterility is not assured. if the product marketed as sterile contains microbial contamination, patients could be at risk for serious, potentially life-threatening infections this alert follows the fda’s notice on 18 may 2013 recommending that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for nuvision pharmacy sterile products, quarantine those products, and not administer them to patients. according to the nuvision pharmacy’s website, injectables using higher strengths of hyaluronic acids in various delivery viscosities have been developed. the company also says that they can formulate products for wrinkle treatment (http://nuvisionpharmacy.Com/?id=13). for details, please visit the following fda website: http://www.Fda.Gov/newsevents/newsroom/pressannouncements/ucm365402.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2013.

Device

Sterile Products
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sterile Products from NuVision Pharmacy
  • Manufacturer
    NuVision Pharmacy

Manufacturer

NuVision Pharmacy