Following on the heels of massive Zantac and other heartburn medication recalls, yet another medication is being recalled due to concerns about NDMA (N-Nitrosodimethylamine). The U.S. Food and Drug Administration (FDA) announced a recall of certain lots of Amneal Pharmaceuticals, LLC Nizatidine Oral Solution. Here is what we know about this latest heartburn medication recall.
Heartburn Medication Recall Information
In April 2020, the FDA posted a Company Announcement stating that Amneal Pharmaceuticals is voluntarily recalling three lots of their Nizatidine Oral Solution product. The recall is due to potential contamination with NDMA at levels exceeding the FDA’s safety guidelines.
The products subject to the recall come in 480 mL bottles at the consumer level. They are distributed by Gemini Laboratories, LLC. Consumers can identify the products in the recall by the following:
Nizatidine Oral Solution, lot numbers:
- 06598004A. Expiration date: 04/2020
- 06599001A. Expiration date: 12/2020
- 06599002A. Expiration date: 12/2020
These products were distributed to wholesalers to then distributed them to pharmacies and directly to consumers. Consumers who use these products should talk to their healthcare provider about their options for continuing the medication or finding a suitable alternative.
Amneal Pharmaceuticals is arranging for returns of the product from pharmacies and consumers. Consumers who have suffered adverse events as a result of the products in this heartburn medication recall should certainly file a report with Amneal Drug Safety. Consumers can call 1-877-835-5472 or email DrugSafety@amneal.com.
Furthermore, Adverse events should also be reported to the FDA via MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
What is Nizatidine?
Nizatidine Oral Solution is a prescription product that doctors prescribe to treat heartburn, ulcers and gastroesophagael reflux disease (GERD). Patients generally use it short-term use as a treatment and to prevent symptoms from reoccurring. Nizatidine is classified as an H2 blocker.
Nizatidine works by decreasing how much stomach acid your body produces. It also relieves symptoms that don’t go away on their own, such as stomach pain, heartburn, coughing and difficulty swallowing. Generally, possible side effects when taking Nizatidine are mild, and may include diarrhea or headache. Serious side effects are rare. However, you should talk to your healthcare provider about any side effects you experience while taking a prescription medication.
Heartburn Medication Recall and NDMA
The World Health Organization (WHO) classifies NDMA as a probable human carcinogen. That is, a product that could cause cancer. NDMA does occur naturally in some foods, water and soil. In the general environment, exposure to NDMA is very slight and should not be a reason for concern. Higher concentrations, such as routinely taking a medication, may cause exposure to exceed safe daily intake limits.
In recent months, there have been several heartburn medication recalls due to possible contamination with higher-than-safe levels of NDMA. Most notably, Zantac recalls and market removal made headlines across the United States. In addition to the recalls, the FDA has also been investigating possible NDMA contamination among other medications, including Metformin.
NDMA has the potential to cause cancer if it is consumed in high doses or in moderate doses over an extended period of time. Research suggests that NDMA may cause cancers including:
Unfortunately, researchers do not know exactly how risky NDMA is, or how likely it is that someone who consumes it could develop cancer. As the FDA and others continue to investigate the link between NDMA and cancer, your best bet is to monitor your health and talk to your healthcare provider about any side effects or unusual symptoms.
Have Questions about a Heartburn Medication Recall?
If you suffer harm or require medical treatment due to a recalled medication, you may be able to pursue compensation. Drug and Device Watch can help you determine if you qualify to file a legal claim against a pharmaceutical company whose negligence caused you to suffer. If you have an actionable claim, you may be able to recover damages, such as the cost of your medical treatment, pain and suffering and more.
To find out what your options may be and to learn more about your legal rights, contact Drug and Device Watch. Request a free legal consultation by calling 1-888-458-6825. You can also complete our online form to learn more.