Dollar Tree gets warning letter about ‘potentially unsafe drugs’ from FDA

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CHESAPEAKE, Va. (WAVY) — The U.S. Food and Drug Administration has issued a warning letter to Chesapeake-based Dollar Tree for receiving “potentially unsafe” drugs from foreign manufacturers.

The letter to Greenbrier International Inc, which does business as Dollar Tree, specifies multiple violations from manufacturers that produce Dollar Tree’s Assured Brand over-the-counter drugs, and other products such as acne treatment pads 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,” 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 FDA says they notified Dollar Tree multiple times in the past about warning letters sent to the contracted drug manufacturers. Those manufacturers were placed on “import alert,” which is used to prevent potentially dangerous products from entering the U.S.

“We note that during the inspection of your corporate headquarters, you stated that if you were made aware that a warning letter was issued to one of your suppliers or contract manufacturers, you would not purchase over-the-counter (OTC) drug products from that contract manufacturer any longer,” the warning letter reads. “Additionally, in your February 5, 2019 response you state, ‘If a drug product is placed on Import Alert 66-40 (appearing not to comply with drug manufacturing cGMPs), Greenbrier ceases importing drug products from that establishment.’ The import data detailed above demonstrate this is not always the case.”

The letters detailed a pattern of “serious violations of the law” from the manufacturers, including failure to test to raw material or finished drugs for pathogens or quality.

In a statement, Dollar Tree says they’re cooperating with the FDA.

“We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe.  Each of the items referenced in the report are topical, and not ingestible, products.  As always, we are cooperating with the U.S. Food and Drug Administration (FDA).  We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards.”

This article will be updated.

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