Warning Letter About OTC Drugs Sent to Dollar Store: FDA - Health, Medical and Fitness News Blog

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Saturday, November 16, 2019

Warning Letter About OTC Drugs Sent to Dollar Store: FDA

Warning Letter About OTC Drugs Sent to Dollar Store: FDA

Dollar Tree has been sent a warning letter for selling over-the-counter (OTC) drugs made by foreign companies with serious, multiple violations of federal manufacturing laws, the U.S. Food and Drug Administration says.

The drugs include Dollar Tree's Assured Brand OTC drugs and other drug products sold by Dollar Tree Co., which operates stores under the Dollar Tree and Family Dollar names.

The contract manufacturers used by Dollar Tree to make the OTC drugs have received warning letters from the FDA for violations such as not testing raw materials or finished drugs for pathogens and quality.

In its warning letter to Dollar Tree, the FDA outlines a number of corrective actions the company needs to take, including a system to ensure that they do not import impure drugs.

Dollar Tree said that it is cooperating with the FDA and plans to meet with the agency, CNN reported.
"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, vice president of investor relations at Dollar Tree, said in a company statement.

"Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration [FDA]. 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.


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