Amneal Pharmaceuticals recalled 3 lots of Nizatidine Oral Solution 15 mg/mL packaged in 480-mL bottles due to potentially hazardous levels of contamination with NDMA (N-Nitrosodimethylamine).

Nizatidine is sold under the brand-names Axid® and Tazac® for the treatment of heartburn, acid reflux, and stomach ulcers.

NDMA is a chemical that may cause cancer in humans. Since 2018, dozens of recalls have been issued for NDMA in heartburn drugs like Zantac® (ranitidine) and blood pressure medications like valsartan.

A growing number of lawsuits have also been filed by people who developed cancer after taking NDMA-contaminated drugs for years.

The recalled nizatidine products were distributed by Gemini Laboratories, LLC, a subsidiary of Amneal Pharmaceuticals.

The recall involves the following 3 lots of Nizatidine Oral Solution:

NDC No. Description Lot Expiration Date
60846-301-15 Nizatidine Oral Solution 06598004A 04/2020
60846-301-15 Nizatidine Oral Solution 06599001A 12/2020
60846-301-15 Nizatidine Oral Solution 06599002A 12/2020

Consumers should talk to a physician or other healthcare provider if they experienced any problems that may be due to this recalled drug.

Source: Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA

Posted by Daily Hornet

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