Home / Business / FDA warns Dollar Tree before selling "potentially unsafe medicines"

FDA warns Dollar Tree before selling "potentially unsafe medicines"

The letter, sent to Greenbrier International Inc., known as Dollar Tree, earlier this month, outlines the receipt of adulterated drugs by Dollar Tree from manufacturers and suppliers who received separate FDA warning letters last year

The letter refers to "multiple violations" of the contract manufacturers' manufacturing practices used to manufacture Assured branded medicines from Dollar Tree and others sold in Dollar Tree and Family Dollar stores Medicines were used. [19659003] Now, in its warning letter to Dollar Tree, the FDA is calling on the company to implement a system to ensure that no adulterated drugs are imported.

"Americans expect and deserve medicines that are safe, effective, and meet our quality standards.The import and distribution of medicines and other products from manufacturers that violate federal law is unacceptable." Donald D. Ashley, director of the Office of Compliance at the FDA's drug evaluation and research center, said in a news release on Thursday.

"In this case, Dollar Tree is ultimately responsible for not selling potentially unsafe medicines and other FDA-regulated products to Americans," he said. "We will continue to be vigilant in protecting the US public from companies that endanger Americans' health, whether through the manufacture and distribution of products we regulate or otherwise."

The company, which operates under the Dollar Tree and Family Dollar brands, announces that it is working with the FDA and plans to meet with the agency.

"We are committed to our customers' safety and have very robust and rigorous testing programs in place." Randy Guiler, Vice President of Investor Relations at Dollar Tree, said in a statement from the company on Thursday that the products of our third-party manufacturers are safe.

"All of the items in this report are current and non-consumable products, and as always, we are working with the US Food and Drug Administration (FDA), and we plan to meet and expect with the FDA in the near future that our plans will meet their requirements in every way, "the statement said.

The company has 1

5 working days to respond to the FDA in writing, states in the warning letter. "Failure to comply with the provisions may result in consequential legal action without further notice, including, without limitation, seizure and arrangement." [19659005] The warning note states that some of the medicines are from Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company Ltd. Pattern of serious violations of law, eg. As the non-testing of raw materials or drugs on pathogens and quality.

The FDA encourages healthcare professionals and consumers to report any adverse events using over-the-counter medicines from contract manufacturers.

Source link