FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

FDA NEWS RELEASE

For Immediate Release: May 18, 2013 Media Inquiries: Curtis Allen, 301-796-0393, curtis.allen@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision Pharmacy of Dallas, Texas. The FDA recommends that these products should not be administered to patients.

If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.

The FDA is basing this expanded alert on a recent inspection of the NuVision Dallas facility, during which FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products.

In April, NuVision recalled methylcobalamin injection and lyophilized injection products due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection. The FDA received adverse event reports of fever, flu-like symptoms, and soreness at the injection site associated with the methylcobalamin injection product that was previously recalled. The agency is not aware of any additional adverse event reports associated with other sterile products from NuVision.

For all sterile products from NuVision, the FDA recommends that health care providers and other health care professionals, including hospital staff, immediately check their medical supplies for NuVision sterile products, quarantine those products, and not administer them to patients.

Patients who were administered any sterile drug products produced and distributed by NuVision and who have concerns should contact their health care provider.

The FDA asks health care providers and consumers to report adverse reactions or quality problems experienced with the use of any NuVision product to the FDA’s MedWatch Adverse Event Reporting program by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Read our Blog: FDA Voice

Visit the FDA on Facebook , Flickr , YouTube , and Twitter

RSS Feed for FDA News Releases

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

You just read:

FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy

Distribution channels: Healthcare & Pharmaceuticals Industry

EIN Presswire's priority is author transparency. We do our best to weed out false and misleading content. The content above is the sole responsibility of the author who makes it available. If you have any complaints, kindly contact the author above.