Axid (nizatidine) drug recalled due to presence of NDMA

Starting date:
May 1, 2020
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Quality
Audience:
General Public
Identification number:
RA-72963

Last updated:

Summary

  • Product: Axid (nizatidine), a prescription drug used to treat ulcers in the stomach and intestine, as well as heartburn.
  • Issue: The Pendopharm Division of Pharmascience Inc. is recalling two lots of Axid from the Canadian market as a precautionary measure, after they were found to contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), at the maximum acceptable limit.
  • What to do: Check the lot number on your product, or contact your pharmacist, to determine whether any of your products are subject to this recall. Talk to your health care provider if you have taken the recalled product and have any concerns about your health. You should not stop taking your medication without first discussing options with your health care provider.

Issue

The Pendopharm Division of Pharmascience Inc. is recalling two lots of Axid (nizatidine) from the Canadian market, as they contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which is a probable human carcinogen, at the maximum acceptable limit. Axid is a prescription drug used to treat ulcers in the stomach and intestine, as well as heartburn.

Test results show that NDMA levels may increase over time for some nizatidine products. The NDMA levels in the two lots being recalled are not higher than acceptable limits at this time, but they could increase with time. As a result, Pendopharm is recalling these lots of Axid from the Canadian market.

NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

In December 2019, Health Canada communicated that it was assessing the issue of NDMA in nizatidine, after U.S. Food and Drug Administration testing detected NDMA in nizatidine.

Health Canada has been working to address the issue of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners to address the issue. The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information.

Should any additional recalls be necessary, Health Canada will update the table below and inform Canadians.

Who is affected

Patients who are taking, or who have taken, Axid (nizatidine) 150mg, or patients who have obtained this product from a pharmacy.

Affected products

The following is a list of Axid drugs is being recalled in Canada at this time:

Company Product Name/Active Pharmaceutical Ingredient (API) DIN Strength Lot Expiry
Pendopharm Division of Pharmascience Inc. AXID CAPS 100 00778338 150mg 616927 31-08-2020
617088 31-08-2020

What consumers should do

  • Check the lot number on your Axid product, or contact your pharmacist, to determine whether any of your product is subject to this recall.
  • Individuals taking a prescription nizatidine drug, including a recalled product, should not stop taking it unless they have spoken to their health care provider and obtained alternative treatment, as the risk of not treating the condition may be greater than the risk related to NDMA exposure.
  • Contact your health care provider if you have taken a nizatidine product and you have concerns about your health.
  • Contact Pendopharm Division of Pharmascience Inc. toll-free at 1-888-550-6060 or by email at med.info@pharmascience.com
  • Report any health product adverse events or complaints to Health Canada

What Health Canada is doing

Health Canada is monitoring the recall and verifying that the company has effectively addressed the issue. Should additional safety concerns be identified, Health Canada will take appropriate action and inform Canadians, as necessary.

Related links

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

Public Enquiries:
(613) 957-2991
1-866 225-0709
hcinfo.infosc@canada.ca