Recall: NDMA Identified in Mylan’s Nizatidine Capsules

Mylan has announced a recall of 3 lots of Nizatidine Capsules as the products were manufactured with an active pharmaceutical ingredient (API) that contained trace amounts of N-nitrosodimethylamine (NDMA), a probable human carcinogen.

Nizatidine, an H₂ blocker, is indicated for the treatment of active duodenal ulcer for up to 8 weeks; for the maintenance treatment of duodenal ulcer for up to 1 year; for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease (GERD) for up to 12 weeks; and for the treatment of active benign gastric ulcer for up to 8 weeks. 

Specifically, the recall involves the following products that were distributed between June 2017 and August 2018:

• Nizatidine Capsules 150mg; bottles of 60;  lot number 3086746, expiry May 2020
• Nizatidine Capsules 300mg; bottles of 30; lot number 3082876, expiry January 2020
• Nizatidine Capsules 300mg; bottles of 30; lot number 3082877, expiry January 2020

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. At the time, the Agency stated that testing revealed low levels of the impurity, although the levels were still above what was deemed acceptable. As such, the FDA recommended that patients taking ranitidine and nizatidine consider alternative therapies such as famotidine, cimetidine, esomeprazole, lansoprazole, and omeprazole (all of which the FDA found did not contain NDMA impurities).

At this time, Mylan has not received any reports of adverse events related to their nizatidine recall. Unexpected effects experienced after the use of these products should be reported to the FDA’s MedWatch Adverse Event Reporting Program.

For more information visit mylan.com.