The US Food and Drug Administration has issued a warning letter to Dollar Tree for the receipt of non-medicated drugs manufactured by foreign manufacturers that have been found to be counterfeit, including acne pimples and drugs from the Assured brand.
The letter – sent earlier this month to Greenbrier International Inc., which operates as Dollar Tree – describes Dollar Tree's receipt of counterfeit medicines from manufacturers and suppliers who had received separate FDA warning letters last year and were placed on "import alert."
The letter describes "multiple breaches" of manufacturing practices by the contract manufacturers used to manufacture Dollar Tree's Assured Brand over-the-counter medicines as well as other drug products sold in Dollar Tree and Family Dollar stores.
Now, in its warning letter to Dollar Tree, the FDA is requesting that the company implement a system to ensure that it does not import counterfeit medicines.
“Americans expect and deserve medicines that are safe, effective and meet our quality standards. Importing and distributing drugs and other products from manufacturers that violate federal law is unacceptable, said Donald D. Ashley, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research, in a news release Thursday.  "In this case, Dollar Tree has ultimate responsibility for ensuring that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans," he said. "We will remain vigilant in our efforts to protect the American public from companies that jeopardize Americans' health – whether through manufacturing and distribution of products we regulate or otherwise."
In response, the company Dollar Tree, which operates stores under the Dollar Tree and Family Dollar brands, said it is partnering with the FDA and plans to meet with the agency.
"We are committed to the safety of our customers and have very robust and rigorous testing programs in place to ensure our third-party manufacturers' products are safe," said Randy Guiler, Vice President of Investor Relations at Dollar Tree, in a company statement on Thursday.  "Each of the articles referenced in the report is relevant and not eligible products. As always, we partner with the US Food and Drug Administration (FDA). We plan to meet with the FDA in the near future and expect our plans to meet their requirements in all respects, "the statement states.
The company has 15 working days to respond to the FDA in writing, the warning letter states, and" the failure to rectifying the violations can lead to legal action without further notice, including, without limitation, seizures and injunctions. "
The warning letter shows how some of the drug products came from Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company Ltd., as the letter contains details of, shows a pattern of serious violations of the law, such as failing to test raw materials or medications for pathogens and quality.
The FDA encourages health care professionals and consumers to report adverse events that may have occurred while using out-of-home medicine products from the contract manufacturers.