On November 20, 2018, Mylan N.V., a global leader in generic drug manufacturing, has recalled several lots of valsartan due to the detect of a cancer causing impurity known as N-Nitrosodiethylamine (NDEA). For more information on the valsartan lots recalled, see our comprehensive listing of specific lots of valsartan confirmed contaminated. Mylan (NASDAQ: MYL) shares fell 2% after officials in the European Union announced that German authorities had detected cancer causing agents in Mylan’s valsartan. The following day Mylan voluntarily recalled select lots of valsartan in the United States and Mylan stock again fell nearly 2%. Is Mylan being forthcoming about the extent of this contamination, or is Mylan is damage control mode? A listing of the valsartan lots recalled by Mylan can be found on our comprehensive list of recalled valsartan page.
Unlike most generic manufacturers, Mylan manufacturers its own active pharmaceutical ingredients (API) through it’s subsidiary Mylan Laboratories Limited located in Hyderabad, Telangana, India. Mylan distributes its generic pharmaceuticals to more than 100 countries. In 2012, Mylan became the first pharmaceutical company to begin manufacturing the high profitable generic drug valsartan. The cancer causing impurity found in valsartan is due to a byproduct formed during the synthesis of a ringed structure called tetrazole that is present within the drug. If the synthesis of tetrazole is in an acidic environment, cancer causing impurities will form. Mylan only recalled batches of contaminated valsartan manufactured between March 2017 and November 2018. However, Mylan did not provide an explanation for why the recall was limited to these dates. Did Mylan change the manufacturing process of valsartan at some point without alerting the FDA? Or is Mylan trying to preserve its stock price by not recalling lots of valsartan that are now expired or already consumed?
Mylan admits on their API web page that “quality begins at step one” and claims that “Mylan uses an established testing and verification process to ensure the suitability of active ingredients used in our medicines.” With such established testing and verification processes in place, did Mylan know all along that the valsartan it was manufacturing was contaminated with carcinogens? Other manufacturers of valsartan began recalling contaminated lots back in July of 2018. Why then did it take take Mylan an additional six months to realize that it was also manufacturing valsartan with cancer causing impurities? The lawyers at the Hollis Law Firm believe there is a lot more to this valsartan contamination than Mylan is sharing with the public. Authorities of the European Union have now stepped in to determine the full extent for Mylan’s contaminated valsartan.
Mylan Valsartan Recall Update
On December 4, 2018, Mylan expanded its voluntary nationwide recall to include all valsartan-containing products within expiry. Mylan claims that the expanded recall is done out of an “abundance of caution.” If Mylan was really being extra cautious, why didn’t they detect their valsartan contamination months earlier like all the other companies did. Mylan’s stock took an even harder hit, dropping 3.4% once the expanded valsartan recall was announced. While Mylan’s initial valsartan recall only impacted 15 lots, the expanded recall encompassed another 104 lots! Mylan continues to remain silent if prior, now expired lots of valsartan were also contaminated with cancer causing agents.
Mylan Valsartan Cancer Lawsuit
The carcinogens within valsartan can result in stomach cancer, colorectal cancer, bowel cancer, liver cancer, liver failure, lymphoma, lung cancer, and kidney cancer, among other cancers. If you have taken contaminated valsartan and developed cancer or a liver injury, call the Hollis Law Firm at 1-800-701-3672. Learn more about the valsartan contamination at our valsartan lawsuit page.