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CEO Testimony May Implicate China As The Source Of Zantac NDMA Contamination

The US FDA exercises little if any regulation over Chinese drug manufacturing

Wednesday, December 16, 2020 - On September 9, 2019, online drug testing pharmacy ignited a firestorm of controversy when they announced they had found high levels of a carcinogenic substance in Zantac tablets. The company found traces of N-nitrosodimethylamine (NDMA), a deadly contaminate by-product of industrial production found in lesser quantities in the air, soil, and water. Both Sanofi Genzyme, the maker of Zantac, and the Food and Drug Administration (FDA) has been aware that Zantac and other medicine tablets contained NDMA, but in levels thought to be safe. The FDA had set the level of NDMA at 96 nanograms as an acceptable limit. Valisure's Zantac NDMA tests came back in the millions of NGS per tablet. Valisure immediately filed a petition with the FDA, and Sanofi recalled the product. After a review, the FDA issued a ban and recall of all ranitidine products generic or otherwise. About wrote, "Using the same detection methods as the FDA, Valisure found 2,511,469 nanograms (ng) of NDMA per 150 mg tablet of Zantac. The FDA's permissible intake limit is 96 ng per day, which means the Zantac tablets contained 26,000 times that." CEO Light also told Congress that the company rejected about 100 drugs every year for being life-threatening, and also that fraud was common in China. Zantac stomach cancer lawyers are national litigators offering a no obligation consultation before filing a claim.

Valisure's CEO David Light testified under oath before Congress regarding his company, what they do, and how they came to the discovery that Zantac NDMA contamination could pose a cancer risk. The degree of urgency demonstrated by the company, the FDA, and Congress is illustrated by over 15 million Americans taking Zantac regularly in the United States. Valisure's pharmaceutical drug testing concerns began when the company discovered that more than 85 percent of the entire drug manufacturing and US distribution chain originates or goes through China and that the FDA had little or no oversight in the manufacturing or testing of the drugs for purity. The company conducts a series of standard tests on the drugs it dispenses and rejects a great number of them for a variety of reasons. As per the CEO's Congressional testimony, "Valisure tests medications for correct dosage, major inactive ingredients, proper dissolution, and the presence of carcinogens such as N-Nitrosodimethylamine (NDMA). Currently, we reject over 10% of on-market medication batches based on these testing standards. With roughly 80 percent of ingredients in U.S. medications manufactured in India and China, medication quality is constantly called into question."

In the wake of the Zantac recall and also CEO Light's sworn testimony, drug manufacturing plants in China have emerged as a prime suspect in the search for the cause of NDMA contamination. Many drug manufacturing plants in China are located near other industrial production facilities and NDMA has been found there at high levels in their water, air, and soil. Other scientists think that NDMA levels were elevated because the drug was stored at high temperatures, while some think that NDMA can increase due to the chemical's interactions with nitrates while in the stomach.

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OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.

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