FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs

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SILVER SPRING, Md. (WDBJ7) - 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 violations of federal law.

The letter outlines 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 letter details Dollar Tree's receipt of drugs from manufacturers that received FDA warning letters in 2018. The 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 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 FDA says the 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 letter to Dollar Tree asks for corrective actions to be taken, including the company implementing a system to ensure 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 here; or
download and complete the form, then submit it via fax at 1-800-FDA-0178.

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