Parker Waichman LLP

Generic Zantac Recalled Due to Nitrosodimethylamine NDMA

Recalls of Heartburn Drugs Raise Alarm Over Impurities in Medications Sold in the U.S. NEW YORK, N.Y. — The U.S. Food and Drug Administration (FDA) sought removal of Zantac and generic forms of Zantac because the active ingredient in those drugs — ranitidine — has the potential to produce a contaminant that is highly suspected […]

Recalls of Heartburn Drugs Raise Alarm Over Impurities in Medications Sold in the U.S.

Generic zantac recalled due to nitrosodimethylamine ndma

Generic Zantac recalled

NEW YORK, N.Y. — The U.S. Food and Drug Administration (FDA) sought removal of Zantac and generic forms of Zantac because the active ingredient in those drugs — ranitidine — has the potential to produce a contaminant that is highly suspected of causing cancer in humans. N-Nitrosodimethylamine (NDMA) is widely regarded as a probable carcinogenic substance, and the contaminant has been turning up in several medications recently. Notably, the FDA recalled high blood pressure medication in 2019 for the same reason. An article in Forbes Magazine identified a more significant issue because of the NDMA impurities. Americans, more now than ever, have a right to demand to know why the medication they are taking could give them cancer in the future.

In 2019, the FDA recalled several high blood pressure medications, and now, with the combined recall of ranitidine and Nizatidine, questions are mounting concerning the safety of the medication we take. The FDA should demand to know why drug makers allow contaminants into their products when the consuming public takes it on faith that the medication is safe to take.

The FDA inquiry should surround the quality control systems of drug makers. All drug manufacturers must have quality controls established and monitored.  However, as we have become keenly aware recently, a large number of the medicines upon which we rely are made internationally. Quality control in other countries can be exceedingly difficult to monitor for the FDA.

Drug manufacturers utilize the cheap labor pools found in countries like China to make their products and ship them to domestic distributors. Pharmaceutical companies save a significant sum of money conducting business in that manner rather than making drugs in the United States.

Drug companies should shoulder much of the blame for allowing impurities into their products. Even the slightest deviation in the manufacturing process could spell disaster for numerous people. Notwithstanding the risk, making the drugs with lower overhead leads to increased profits for the companies.

The U.S. government shoulder some of the blame too. The government allows companies to make medications internationally but sell them domestically. Instead, the U.S. government should incentivize domestic manufacturing, which will decrease the chance that impurities will threaten people’s lives.


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