The FDA has issued warnings to at least 28 manufacturers of over-the-counter medications and health products this year for failing to adequately test ingredients for toxins that caused hundreds of deaths overseas, according to a Sept. 26 exclusive report from Reuters.
Manufacturers that received the warnings include U.S.-based companies, as well as some based in India, South Korea, Switzerland, Canada and Egypt, according to the report, which is based on Reuters' analysis of FDA import alerts and manufacturer warning letters. Specifically, the FDA warnings are centered on testing for the presence of ethylene glycol and diethylene glycol — toxins found in cough syrups made in India and Indonesia that have been linked to the deaths of more than 300 children worldwide. The toxins can be byproducts from the manufacture of ingredients found in over-the-counter medications and products like toothpaste and sunscreen.
There have been no signs contaminated products have entered the U.S. supply chain, the FDA told the news outlet. Warnings sent to the manufacturers threaten to block product exports or imports and new drug applications if testing practices are not improved.