Dollar Tree stores receives FDA warning letter for potentially unsafe drugs
The U.S. Food and Drug Administration issues a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for obtaining over-the-counter drugs by foreign manufacturer production that may have serious violations of federal law. The warning letter references multiple violations of current good manufacturing practices at contract manufacturers that produce Dollar Tree’s Assured Brand OTC drugs. In addition, other drug products sold at the Dollar Tree and Family Dollar stores.
According to the FDA press release, the warning letter details Dollar Tree’s receipt of adulterated drugs from manufacturers that received FDA warning letters in 2018. The warning letter also details Dollar Tree’s use of contract manufacturers that also received warning letters for similar issues between 2016 and 2019, per the release. Manufacturers that received these warning letters were placed on import alert, which are used to prevent potentially violative products from being imported into the U.S. market. The FDA notified Dollar Tree of warning letters sent to these manufacturers at the time the warning letters 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 FDA press release states. The FDA’s warning letter to Dollar Tree details the corrective actions the agency requested. Among those, the FDA has requested the company implement a system to ensure that they do not import adulterated drugs.
The two main ways to report adverse events to the FDA’s MedWatch Adverse Event Reporting program are by completing and submitting the report online; or, download and complete the form, then submit it via fax at 1-800-FDA-0178.