FDA warns Dollar Tree regarding ‘potentially unsafe’ drugs
The FDA has sent a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter drugs made by foreign manufacturers that were found to have serious violations of federal law.
According to the press release, the warning letter also described multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs and other drug products sold at Dollar Tree and Family Dollar; detailed Dollar Tree’s receipt of adulterated drugs from manufacturers that previously received FDA warning letters; and described Dollar Tree’s use of contract manufacturers that received warning letters for similar issues prior to today’s announcement.
“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 stated, adding that the letter to Dollar Tree provides information on how Dollar Tree can correct the alleged actions.
“The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the press release. “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.”
Randy Guiler, Dollar Tree’s vice president of investor relations, told Healio Primary Care the company is “committed to our customers’ safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers’ products are safe. Each of the items referenced in the report are topical, and not ingestible, products.”
Guiler added that the company is cooperating with the FDA and plans to meet with the FDA in the “near future and expect that our plans will satisfy their requirements in all regards." - by Janel Miller
Editor’s note: This story has been updated to reflect comments by Dollar Tree.