The Food and Drug Administration says it has sent a warning letter to Dollar Tree stores, saying the retailer received "potentially unsafe" over-the-counter drugs from foreign manufacturers who have violated federal law.
The warning relates to Dollar Tree's "Assured" brand over-the-counter drugs along with other drug products the FDA says were sold at Dollar Tree and Family Dollar stores.
The FDA claims Dollar Tree accepted poorly produced drugs from manufacturers that received a warning from the agency in 2018. The FDA also claims Dollar Tree has used contract manufacturers that received FDA warnings for similar issues between 2016 and 2019.
The FDA says the letters sent to the contract manufacturers claim they did not test raw materials or finished drugs for pathogens and quality. It claims Dollar Tree was made aware when it sent the warning letters to these manufacturers and that it requested the retailer "implement a system to ensure that they do not import adulterated drugs."
"The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” Donald D. Ashley, FDA director of the Office of Compliance in the Center for Drug Evaluation and Research, said in a statement.
Dollar Tree says it is cooperating with the FDA.
"We are committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe," a company spokesperson said in a statement Friday. "Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration (FDA). We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards."
The FDA is asking health care professionals and consumers to report any adverse events to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
