If you have bought over-the-counter topical medications from Dollar Tree, Inc., you may want to throw them out.
The company apparently bought medicines for its Assured brand label that were made in such substandard conditions that they were barred from the United States. And, even though the FDA warned them of the problem as soon as 2017, the company continued to receive and sell the drugs in violation of the Food, Drug and Cosmetic Act.
Now, the FDA has sent a warning letter to the company about continuing to source medical products from Shanghai and other international cities that have been flagged by the agency.
According to Dollar Tree, all of the medications in question are topical, as opposed to items that would be ingested. Bloomberg reports that the FDA letter was redacted, so that only one affected item was visible: acne treatment pads.
“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,” said a Dollar Tree spokesperson.
However, the letter details violations that imply otherwise. For example, it accuses Dollar Tree of failing to test ingredients or finished products to ensure they contain what is expected. It also says Dollar Tree failed to ensure the products were manufactured to the correct specifications and did not check the products for contaminants like microorganisms even though at least one manufacturing facility for Dollar Tree was riddled with rodent feces which could have contaminated the products.
Dollar Tree also asserted that it was not notified that the cities or facilities had been placed on import alert and that it would not have imported the products if it had known. The FDA disputes that assertion.
Drug makers increasingly manufacturing abroad for low costs
As Bloomberg notes, pharmaceutical manufacturers have been increasingly having their products manufactured abroad in order to take advantage of less regulation and lower overall costs. Unfortunately, the FDA and other regulators are having a hard time inspecting the growing number of foreign manufacturers, even though there are questions about their safety mechanisms.
“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,” said an FDA spokesperson.
Dollar Tree has 15 days to provide an action plan to the FDA, beginning on the date of the letter, Nov. 6.
If you have used Dollar Tree Assured brand medications and became sick or injured, you should save the packaging and contact an attorney experienced in product liability law.