WASHINGTON (WKBN) – The U.S. Food and Drug Administration is warning Dollar Tree to stop buying some over-the-counter medications from companies that are already under scrutiny.
The letter sent Thursday to Dollar Tree’s distributor, Greenbrier International, Inc., warns against purchasing adulterated drugs from suppliers that have been warned by the FDA previously.
The warning letter outlines multiple violations 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.
“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 drug manufacturers at the center of the concern received FDA warning letters between 2016 and 2019 and placed on import alert.
The FDA notified Dollar Tree about the warning letters when they were sent.
Some of the violations by the manufacturers include not testing raw materials or finished drugs for pathogens and quality.
The FDA now wants Dollar Tree to implement a system to ensure that 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 at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.