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.
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