Discount retailer Dollar Tree is facing heat from the Food and Drug Administration (FDA) over its imports of potentially dangerous over-the-counter drugs. The company received acne treatment pads and other drug products from overseas manufacturers that the FDA considers suspect because they have been repeatedly warned about manufacturing quality violations. Dollar Tree used the manufacturers to produce its Assured Brand OTC drugs and drug products sold at its 15,000 Dollar Tree and Family Dollar stores.
Both the manufacturers and Dollar Tree received FDA warning letters. “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,” Donald D. Ashley, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in a statement. Specifically, the company was cited for not “testing finished drug products prior to distribution for rodent feces found throughout the manufacturing facility.”
Ultimately, the FDA placed the manufacturers’ products on import alert designed to prevent their products from being imported into the United States. Despite Dollar Tree’s claims that it had stopped importing products from the manufacturer, the FDA found that it still was.
Dollar Tree was instructed in its own FDA warning letter corrective actions required to ensure that the company does not import adulterated drugs.
“The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” Ashley said in the statement. “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans.”