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FDA Warns Dollar Tree for Stocking 'Potentially Unsafe Drugs'

National chain received over-the-counter products from cited foreign manufacturers

Dollar Tree
Kristoffer Tripplaar/Alamy Stock Photo

Dollar Tree was issued a warning letter from the Food and Drug Administration (FDA) last week for receiving “potentially unsafe” over-the-counter drugs from foreign companies that the government says are not following proper manufacturing practices.

These offshore manufacturers produce Dollar Tree's Assured brand of over-the-counter drugs and other health care products, including acne treatment pads, sold at Dollar Tree and Family Dollar stores, according to the FDA. Randy Guiler, Dollar Tree's vice president of investor relations, said in a statement that the acne pad and an antibacterial wipe are the products he's “aware of” that come from the manufacturers cited by the FDA.

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The agency says that some of these companies failed to test raw materials and the finished products before distributing them, while others falsified test results and had rodent feces in their facilities. These manufacturers have in the past received warning letters of their own from the FDA. Dollar Tree was notified when these warning letters were sent, the FDA says. The FDA has not issued any formal recall of the affected products.

"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,” Donald D. Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said in a statement.

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Ashley added that Dollar Tree has “the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans,” and that the FDA will “remain vigilant” to protect the public from companies who put Americans’ health at risk.

Guiler said in his statement that Dollar Tree is committed to customer safety and has “very robust and rigorous testing programs in place” to ensure 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. We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards,” he said.

Dollar Tree has 15 days to respond to the warning letter. The FDA has asked the company to provide a detailed plan to ensure they do not “receive or deliver adulterated drugs in interstate commerce.”

The federal agency also asked the company to determine if any drugs from the outlined manufacturers are in their distribution network or in retail stores under the Dollar Tree or Family Dollar brands, or any other brands in the network.

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