The Food and Drug Administration issued a warning letter to Greenbrier International Inc., for selling over-the-counter drugs at its Dollar Tree and Family Dollar stores from Chinese manufacturers with “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
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.
“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.
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.