Dollar Tree Receives Warning Letter

November 15, 2019

FDA issued a warning letter to the company for obtaining over-the-counter drugs made by foreign manufacturers that violated federal law.

FDA issued a warning letter, dated Nov. 6, 2019, to Greenbrier International, Inc., operating as Dollar Tree, for obtaining over-the-counter (OTC) drugs made by foreign manufacturers that violated federal law. FDA found multiple violations of current good manufacturing practices at the 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.

In 2018, Dollar Tree received warning letters regarding its receipt of adulterated drugs and, in 2016 and 2019, the company received warning letters for its use of contract manufacturers. The recipients of the letters were put on import alert, which restricts violative products from being imported into the US market.   

The warning letters outlined serious violations of the law, including not testing raw materials or finished drugs for pathogens and quality, according to FDA. The current warning letter requests corrective actions and a system implementation that ensures adulterated drugs are not sent to the US market.

“Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place US 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 FDA’s Center for Drug Evaluation and Research, in a statement issued by the agency. “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 US public from companies who put the health of Americans at risk-whether through the manufacturing and distribution of products we regulate or other means.”

Source: FDA