FDA Warns Dollar Tree for Importing Unsafe OTC Drugs
The US Food and Drug Administration (FDA) on Thursday released a warning letter sent to the owner of Dollar Tree and Family Dollar stores for importing over-the-counter (OTC) drugs from contract manufacturers that had been banned from importing products to the US.The warning letter says that the firm received acne treatment pads from China-based Shanghai Weierya Daily Chemicals Factory, which was placed on import alert in September 2017 and received a warning letter in February 2018.
Dollar Tree and Family Dollar stores also received drug products from China-based Hangzhou Zhongbo Industrial Company, which was placed on import alert in September 2018 and received a warning letter in November 2018.
Both warning letters sent to Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company were also sent to the chief operating officer (COO) of Greenbrier International, which does business as Dollar Tree.
Although Greenbrier said it does not import from companies put on import alert by FDA, the agency also pointed to four other examples of contract manufacturers used by Dollar Tree even after they were put on import alert and after FDA sent the Greenbrier COO the warning letters.
For instance, China-based Bicooya Cosmetics Limited received a warning letter detailing how “rodent feces [was] found throughout the manufacturing facility” and the contract manufacturer was later put on import alert, while China-based Ningbo Pulisi Daily Chemical Products Company received a warning letter in August for not testing raw materials and was put on import alert.
Donald Ashley, director of FDA’s Office of Compliance in the Center for Drug Evaluation and Research, said: “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. We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk.”
Warning Letter