Dollar Tree gets FDA warning over 'potentially unsafe' drugs

Grant Boone
November 16, 2019

Regulators' concerns revolve around manufacturers Dollar Tree used to produce its "Assured Brand" drugs and other products sold at its stores.

Even after the FDA notified the company that these Chinese contract manufacturers and suppliers had received warning letters, and their products had been banned from the US, some of these products still made to the shelves of Dollar Tree, a company that generated $22.8 billion in 2018 sales.

The manufacturers had received their own FDA warning letters in recent years and were also placed on import alert, a measure meant to stop the flow of sketchy products into the U.S., federal officials say.

The agency says Dollar Tree was notified of these violations multiple times between 2016 and 2019. "We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards", the statement said, CNN reported. The agency cited Dollar Tree supplier Bicooya Cosmetics for actions including "not testing finished drug products prior to distribution and for rodent feces found throughout the manufacturing facility".

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Donald D. Ashley, director of the office of compliance in the FDA's Center for Drug Evaluation and Research, said Dollar Tree is responsible for ensuring it doesn't sell unsafe drugs. In August, New York officials fined Dollar Tree and Family Dollar, plus Dollar General, a separate company, for selling expired products, including drugs.

The FDA has instructed Dollar tree to respond to the letter within 15 days and to detail what they've done to address their violations. "We will remain vigilant in our efforts to protect the USA public from companies who put the health of Americans at risk - whether through the manufacturing and distribution of products we regulate or other means". 6 warning to Greenbrier International says that the company continued to receive products from companies on "import alert", even after Greenbrier International agreed not to.

Customers who used the questionable drugs can report any negative side effects to the FDA online.

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