On April 15th, 2020 Amneal Pharmaceuticals announced that it is voluntarily recalling three lots of Nizatidine Oral Solution, a heartburn medication. The FDA found the impurity NDMA (N-nitrosodimethylamine), which is classified as a probable human carcinogen based on results from laboratory tests in the drug.
About Nizatidine
Nizatidine is an oral product used for the short-term treatment of active duodenal ulcers and benign gastric ulcers. This maintenance therapy for duodenal ulcer patients should only be used for a year. Those with GERD can use the drug for 12 weeks to aid with endoscopically diagnosed esophagitis. About 15 million Americans take Proton Pump Inhibitors (PPIs) like Nizatidine each year.
About NDMA
NDMA is a chemical component used in aviation and rocket fuel and industrial lubricants. It is also a by-product of several industrial processes, including gasoline refining and the treatment of wastewater containing nitrogen. Also, researchers use NDMA to cause cancer in rats. The Federal Emergency Planning and Community Right-to-Know Act of 1986 classified NDMA as extremely hazardous. Around 1 in 1000 people will get cancer due to NDMA. No dose is risk-free, however, the FDA said a daily limit of the chemical is 96 ng. NDMA is so potent that it’s only practical purpose is the toxin of choice to induce tumors in lab animals. NDMA initiates and promotes cancer growth.
Nizatidine Recall
Amneal Pharmaceuticals has recalled three lots of Nizatidine Capsules due to researchers finding trace amounts of N-nitrosodimethylamine (NDMA). Specifically, the recall involves the following products distributed between June 2017 and August 2018:
- 150mg Nizatidine Capsules; bottles of 60; lot number 3086746, expiry May 2020
- 300mg Nizatidine Capsules; bottles of 30; lot number 3082876, expiry January 2020
- 300mg Nizatidine Capsules; bottles of 30; lot number 3082877, expiry January 2020
Also, in November 2019, the Food and Drug Administration (FDA) released a summary of results from tests evaluating ranitidine, another H2 blocker, for the presence of NDMA.
Other NDMA Recalls
On April 1, 2020, the FDA requested that all makers of all ranitidine drugs (Zantac and generics) remove their products from the market.
The FDA has also ordered recalls of entirely different drugs where NDMA impurities were found:
Free Nizatidine Recall Consultation
Therefore, if you have experienced stomach, bladder, kidney, pancreatic or colon cancer after taking Nizatidine for a year, you may be eligible for compensation to offset your financial, physical and emotional burdens. Contact us today to set up a free consultation during which we will listen to your story and discuss your legal rights and options. If you choose us to represent you, we will work with you on a contingency fee basis; this means you pay nothing until we have secured compensation for you, either through a jury verdict or settlement.
