• FDA’s new warning letter is asking Dollar Tree to ensure the company does not import adulterated medicines
   
• Manufacturers mentioned in the letter include Hangzhou Zhongbo and Shanghai Weierya Daily Chemicals

Reports confirm that the U.S. Food and Drug Administration recently sent a warning letter to Virginia-based Greenbrier International, trading as Dollar Tree, about receiving OTC drugs made by foreign companies which have been discovered as being adulterated. These include Assured branded drugs as well as acne treatment pads.

Apparently, the manufacturers and suppliers in concerns have already received separate warning letters from the FDA last year, besides being placed on import alert. The letter enumerated several manufacturing practice violations at the facilities of these manufacturers, who produce the Assured brand OTC drugs of Dollar Tree and other products sold by the company and its outlets.

FDA’s new warning letter is asking Dollar Tree to adopt systems for ensuring the company does not import adulterated medicines. Responding to the letter, Dollar Tree has confirmed it is co-operating with the U.S. FDA and has plans for meeting with the federal agency.

Dollar Tree’s vice president for investor relations, Randy Guiler said the company is committed towards the safety of its customers and has implemented strong, rigorous testing programs to ensure the products from its third-party manufacturers are safe.

According to the warning letter, Dollar Tree has 15 working days for responding to the FDA in writing, whereas any failure to correct the violations quickly may lead to legal actions, without further notice. The FDA has requested consumers as well as healthcare professionals to report any adverse events resulting from the use of these OTC drugs produced by the contract manufacturers.

Some of the manufacturers mentioned in the letter include Hangzhou Zhongbo Industrial Company Ltd and Shanghai Weierya Daily Chemicals Factory. It has been indicated that these companies do not meet the requirements to test raw materials and drugs for pathogens and quality.

Director of the Office of Compliance at the Center for Drug Evaluation and Research, FDA, Donald D. Ashley commented that Americans deserve medicines which are safe, effective and comply with the agency's quality standards. Importing and distributing products from manufacturers that are in violation of the federal law is unacceptable, he sternly mentioned.

Source Credits: https://edition.cnn.com/2019/11/14/health/fda-dollar-tree-warning-bn/index.html