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FDA warned Dollar Tree stores for receiving potentially unsafe drugs

Christian Fernsby |
The U.S. Food and Drug Administration has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law.

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Topics: FDA    DOLLAR TREE    DRUGS   

The warning letter outlines multiple violations of current good manufacturing practices 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 warning letter details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018.

The warning letter also details Dollar Tree’s use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019.

Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market.

The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters were sent.

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

The FDA’s warning letter to Dollar Tree details the corrective actions the agency requested.

Among those, the FDA has requested the company implement a system to ensure that they do not import adulterated drugs.

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