FDA issues warning about Dollar Tree’s over-the-counter drugs

The Food and Drug Administration sent a warning letter to Greenbrier International, Inc. which is doing business as Dollar Tree, for receiving over-the-counter drugs from foreign manufacturers with a pattern of violations of federal law.

The letter outlined violations by the contract manufacturers of Dollar Tree's Assured Brand of OTC drugs.

According to Bloomberg, the letter outlined flaws at facilities in Shanghai as well as other foreign cities which were detected by the FDA between 2017 and 2019. Though this was brought to the attention of both Dollar Tree and the manufacturers, Dollar Tree continued to receive the product, thus violating section 30 I (c) of the Federal Food, Drug and Cosmetic Act (FD&C Act).

The FDA’s warning letter to Dollar Tree detailed the corrective actions and the FDA requested the company implement a system to ensure that they do not import adulterated drugs.

Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, commented on the letter in an FDA news release:

"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. 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, that was dated Nov 6, gave Greenbrier 15 days to respond to the FDA with a plan to correct violations and prevent it from happening again.

Dollar Tree operates more than 15,000 stores in the U.S. and Canada under the Dollar Tree, Family Dollar and Dollar Tree Canada brands.

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