FDA warns consumers about Dollar Tree drugs, cosmetics

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The discount retailer has received acne treatment pads and other products from foreign manufacturers that have committed "serious" violations of federal standards, the US Food and Drug Administration said in a November 6 warning letter to the company.

It also mentioned a facility where rodent feces were found.

The letter, dated November 6, outlines violations by manufacturers of Dollar Tree's Assured Brand of over-the-counter drugs in Shanghai and other cities.

"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.

"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 agency said Thursday in a news release.

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Dollar Tree and a competitor, Dollar General, were fined $1.2 million were selling expired over-the-counter drugs, the NY attorney general announced in August.

The letter also goes into detail about Dollar Tree's alleged use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019.

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. As always, we are cooperating with the U.S. Food and Drug Administration [FDA].

Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the US market. But the FDA delineated cases in which Greenbrier still received products from the CMOs after the agency had copied its chief operating officer on the warning letters that were issued.

The warning letter asks Dollar Tree to take corrective actions, including implementation of a system to make sure the retailer does not import adulterated drugs in the future. Reports can be submitted online.

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