Important Safety Alerts

Important Safety Alerts

Medical Device Safety Alert: Sterile Products from NuVision Pharmacy

19 Aug 2018

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

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