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.