The U.S. Food and Drug Administration issued a warning letter to the parent company of Dollar Tree and Family Dollar for receiving over-the-counter drugs produced by foreign manufacturers found to have “serious violations of federal law,” officials said Thursday.
Dollar Tree received drugs for its Assured brand and other products from manufacturers that got warning letters last year for multiple violations of good manufacturing practices, according to the FDA’s letter. And Dollar Tree has also used manufacturers that received warning letters for similar issues since 2016.
The manufacturers “show a pattern of serious violations of the law,” like failing to test raw materials or finished drugs for pathogens or quality, according to the FDA.
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.
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“Americans expect and deserve drugs that are safe, effective and that meet our standards for quality,” Ashley said in a press release. “The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable.”
The FDA is requiring Dollar Tree to implement a system to ensure its drugs are safe. The company will have 15 days to respond after receiving the government’s notice.
This wasn’t the first time the chains have gotten in trouble this year over their over-the-counter drugs. In August, New York officials fined Dollar Tree and Family Dollar, plus Dollar General, a separate company, for selling expired products, including drugs.
FDA officials said any health care professionals or consumers who want to report “adverse events” to the FDA’s MedWatch program can use this link.
“We will remain vigilant in our efforts to protect the U.S. public form companies who put the health of Americans at risk — whether through manufacturing and distribution of products we regulate or other means,” Ashley said.