The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found. The Food and Drug Administration has reprimanded at least 28...
The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found.
The FDA told Reuters it has no indication products contaminated with DEG and EG have entered the U.S. supply chain, and that the number of warning letters issued in a given period "is not a comprehensive marker of our oversight." Cough syrups made in India and Indonesia have been linked to deaths of more than 300 children globally. The medicines were found to contain high levels of DEG and EG, leading to acute kidney injury and death. The poisonings have sparked criminal probes, lawsuits and a surge in regulatory scrutiny worldwide. Reuters reported earlier this month that some Indian drugmakers involved could not prove they had purchased pharmaceutical grade ingredients or tested their medicines for the toxins.
Previous guidance from 2007 recommended certain tests be performed on glycerin, another common ingredient in over-the-counter drugs and consumer goods, to prevent distribution of DEG-contaminated products. It now requires the same scrutiny of PG and other high-risk components for DEG and EG.The FDA warning letters give manufacturers an opportunity to fix quality control problems or face penalties.
Florida-based Lex, a contract manufacturer of cough and cold medicines that can be used by children, was called out by the FDA on Aug. 17 for lax testing and repeated quality-control violations going back to 2004. Four of the 14 companies were put on an import alert list for not responding to requests for records. They are Daxal Therapeutics and Skyline Herbals from India, and South Korea’s KM Pharmaceutical and Sangleaf Pharma. They could not be reached for comment.
Australia Latest News, Australia Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Cough syrup deaths overseas prompts US crackdown on toxic testingThe U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups.
Read more »
FDNY first responder deaths from 9/11-related diseases now equal FDNY deaths from attacksTwo more members of the FDNY died this September from 9/11-related illnesses, shortly after the 22nd anniversary of the World Trade Center attacks.
Read more »
Elon Musk says Neuralink can create the 'Luke Skywalker solution' amid claims over monkey deathsElon Musk claims Neuralink could produce Star Wars-style robotic hands, and help save the world from AI.
Read more »