(WSPA) – The U.S. Food and Drug Administration officials said they have issued a warning letter to Greenbrier International, Inc. — doing business as Dollar Tree — for reportedly receiving possibly unsafe drugs.
According to the FDA news release, Dollar Tree stores received over-the-counter drugs produced by foreign manufacturers “found to have serious violations of federal law.”
The letter allegedly outlined several violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs, and 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,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said. “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.”
According to the release, the letter detailed the company’s receipt of adulterated drugs from manufacturers that were given 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,” according to the release. “The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters were sent.”
Consumers can complete and submit a report of any adverse events to the FDA’s MedWatch Adverse Event Reporting program here.
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