Dollar Tree received and sold over-the-counter drugs produced by foreign drugmakers that routinely violated federal law, according to a Nov. 14 warning letter from the FDA.
The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers Dollar Tree used to produce its Assured Brand drugs.
The FDA said Dollar Tree received tainted drugs from manufacturers that had received FDA warning letters in 2018 and used contract manufacturers that received warning letters between 2016 and 2019.
The FDA said it notified Dollar Tree of the warnings against the manufacturers at the time they were sent.
"The warning letters sent to the 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 wrote.
The contract manufacturers also were placed on import alert, which the FDA uses to prevent potentially dangerous products from being imported to the U.S.
Dollar Tree reportedly worked with contract manufacturer Bicooya Cosmetics Limited, which received a warning letter and was placed on import alert in 2017 for failing to test its finished
drug products before distribution and for rodent feces in its facility, according to CNBC.
Dollar Tree's vice president of investor relations, Randy Guiler, told CNBC that the items referenced in the warning letter are topical, not ingestible products. He also said the company is cooperating with the FDA and plans to meet with the agency soon.
The FDA has requested Dollar Tree implement a system to ensure it does not import potentially harmful adulterated drugs.