FDA NEWS RELEASE
For Immediate Release: May 18, 2013
Media Inquiries: Curtis Allen, 301-796-0393, email@example.com
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.
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.
- 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.
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.
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