FDA flags Dollar Tree for selling over-the-counter drugs from companies with ‘serious violations’

By | November 15, 2019

People walk by a Dollar Tree store on December 11, 2018 in the Brooklyn borough of New York City.

Spencer Platt | Getty Images News | Getty Images

Dollar Tree stocked over-the-counter drugs produced by Chinese companies with “a pattern of serious violations” of federal law on good manufacturing practices, the Food and Drug Administration said in a warning letter sent to the company Thursday.

The FDA analyzed import data and found Dollar Tree bought and received products from foreign companies that had received warning letters and had been placed on import alert for manufacturing issues. The agency also alleges that Greenbrier, operating as Dollar Tree, has used contract manufacturers and suppliers with “significant” violations for its private-label 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 Ashley, compliance director in the FDA’s Center for Drug Evaluation and Research, said in a statement.

The FDA said it inspected Greenbrier’s headquarters in January and its distribution warehouse after uncovering violations at multiple foreign drug companies that supplied the U.S. retailer, according to the warning letter.

For example, the FDA said Greenbrier worked with Bicooya Cosmetics Limited, a company that received a warning letter and was placed on import alert in 2017 for not testing finished drug products before distribution and for rodent feces found throughout the manufacturing facility.

“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,” Randy Guiler, Dollar Tree’s vice president of investor relations, said in a statement.

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Guiler said each of the items referenced in the letter are topical, not ingestible products. He said the company is cooperating with the FDA and plans to meet with the agency in the near future.

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