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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 (http://www.fda.gov/medwatch) completing and submitting the report online at (http://www.fda.gov/medwatch/report.htm) or by downloading and completing the form (http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM082725.pdf, then submitting it via fax to 1-800-FDA-0178.

SOURCE:

FDA

May 20, 2013



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