SILVER SPRING, Md., Nov. 14, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree's Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores.
"Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable," said Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means."
The warning letter details Dollar Tree's receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. The warning letter also details Dollar Tree's use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters were sent.
The warning letters sent to the contract manufacturers used by Dollar Tree show a pattern of serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality. The FDA's warning letter to Dollar Tree details the corrective actions the agency requested. Among those, the FDA has requested the company implement a system to ensure that they do not import adulterated drugs.
The agency encourages health care professionals and consumers to report any adverse events to the FDA's MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 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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SOURCE U.S. Food and Drug Administration