FDA warns Dollar Tree about selling potentially unsafe drugs

FDA warns Dollar Tree about selling potentially unsafe drugs

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The US Food and Drug Administration sent a warning letter to Dollar Tree for receiving over-the-counter products from foreign manufacturers that have been degraded. 

The products include acne treatment pads and Assured brand drugs. 

“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,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in a release Thursday. “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.”

According to the FDA, Dollar Tree received adulterated drugs from suppliers that were placed on the FDA's import alert list last year. The letter also outlines multiple violations by manufacturers used by to produce Dollar Tree's Assured Brand drugs. 

"Import alerts inform the FDA's field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of the FDA's laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information," the FDA website states. 

Dollar Tree said it is 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,” a Dollar Tree statement said. "“Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the US 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."

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