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FDA Warns Dollar Tree On Adulterated Drugs

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Greenbrier International, Inc., doing business as Dollar Tree, received a warning letter from the U.S. Food and Drug Administration for receiving potentially unsafe drugs.

In a statement, the FDA noted that Dollar Tree, which operates a chain of supermarkets, received over-the-counter or OTC drugs made by foreign manufacturers in violation of federal law.

To correct this, the agency has requested the company implement a system to ensure that they do not import adulterated drugs.

The issue is with Dollar Tree's Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. In the letter, the regulator outlines multiple violations of current good manufacturing practices at Dollar Tree's contract manufacturers of these drug products.

The regulator noted that Dollar Tree received adulterated drugs from manufacturers that received FDA warning letters in 2018. The company also use contract manufacturers that received warning letters for similar issues between 2016 and 2019.

The warning letters sent to the contract manufacturers show serious violations of the law, such as not testing raw materials or finished drugs for pathogens and quality.

According to the FDA, the warned manufacturers were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market.

The regulator had also notified Dollar Tree at the time of sending those warning letters to manufacturers.

Donald Ashley, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, said, "The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable. Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans."

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