Information Update - Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; additional products being recalled

UPDATE: September 25, 2019

Additional ranitidine drugs are being recalled by four companies: Apotex Inc., Pro Doc Limitée, Sanis Health Inc., and Sivem Pharmaceuticals ULC. The lots are being recalled as they may have been manufactured using an active pharmaceutical ingredient containing an impurity, N-nitrosodimethylamine (NDMA), above acceptable levels. Please refer to the Affected Products table below for detailed information on the recalled lots.

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

Original Information Update: September 17, 2019

OTTAWA, Sept. 25, 2019 /CNW/ - Health Canada recently informed Canadians that it is assessing the issue of an impurity called N-nitrosodimethylamine (NDMA) detected in some ranitidine drugs. Current evidence suggests that NDMA may be present in ranitidine, regardless of the manufacturer. As a result, and at Health Canada's request, companies marketing ranitidine products in Canada have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.

Equate 50 tablets (CNW Group/Health Canada)

Equate 84 tablets (CNW Group/Health Canada)

Selection 50 tablets (CNW Group/Health Canada)

The request to stop distribution means that the existing stock of ranitidine products currently available in pharmacies or at retail stores may continue to be sold. This is different from a recall, since products that are being recalled can no longer be sold.

This is an interim, precautionary measure as Health Canada continues to gather information from companies and to assess the issue with other international regulators.

One company, Sandoz Canada, is recalling its oral prescription products in Canada and other countries after testing identified levels of NDMA above what is considered acceptable if the drug were to be taken over a lifetime. Should any additional recalls be deemed necessary, Health Canada will update the table below and inform Canadians.

Ranitidine is available in Canada over-the-counter (for example, under the brand name Zantac and as generics) and by prescription (as generics). Over-the-counter ranitidine is approved to prevent and relieve heartburn associated with acid indigestion and sour stomach. Prescription ranitidine drugs are used to reduce stomach acid for the treatment and prevention of various conditions, such as heartburn, ulcers of the stomach and intestines, and gastroesophageal reflux disease (commonly known as GERD).

NDMA is classified as a probable human carcinogen, which means long-term exposure to levels above what is considered safe could increase the risk of cancer. We are all exposed to low levels of NDMA in some foods (such as meats, dairy products and vegetables) and in drinking water. NDMA is not expected to cause harm when ingested at very low levels.

Health Canada continues to gather and share information with other regulators, including the U.S. Food and Drug Administration and the European Medicines Agency, and with Canadian companies to better understand the issue and whether there may be a risk to Canadians. This includes conducting its own tests and assessing whether the results seen in laboratory tests present a human health risk. The Department will take action if a risk to Canadians is identified, and will continue to inform the public of new safety information.

Health Canada has been working to address the issue of NDMA and similar impurities, known as nitrosamines, found in certain "sartan" angiotensin receptor blocker (ARB) blood pressure medications since 2018. Health Canada continues to work closely with international regulatory partners to address the issue. This includes broadening its efforts to evaluate the potential for nitrosamines in drugs other than sartans and measures to address and prevent the impurities.

Who is affected
Consumers and patients who are taking a ranitidine drug.

Affected products
Companies have agreed with Health Canada's precautionary request to stop distributing all ranitidine drugs in Canada. A complete list of ranitidine products marketed in Canada is available by searching Health Canada's Drug Product Database.

The following is a list of ranitidine products being recalled in Canada at this time:

Company	Product  Name/Active Pharmaceutical Ingredient (API)	DIN	Strength	Lot	Date added
Apotex Inc.	Acid Reducer (ranitidine) sold under the brand names Equate and Selection	02296160	150 mg	All lots	September 25, 2019
Apotex Inc.	Apo-Ranitidine Oral Solution	02280833	15 mg/mL	All lots	September 25, 2019
Apotex Inc.	Apo-Ranitidine Tablet 150mg	00733059	150 mg	All lots	September 25, 2019
Apotex Inc.	Apo-Ranitidine Tablet 300mg	00733067	300 mg	All lots	September 25, 2019
Pro Doc Limitée	Ranitidine - 150	00740748	150 mg	All lots	September 25, 2019
Pro Doc Limitée	Ranitidine - 300	00740756	300 mg	All lots	September 25, 2019
Sandoz Canada	Sandoz Ranitidine	02243229	150 mg	All lots	September  17, 2019
Sandoz Canada	Sandoz Ranitidine	02243230	300 mg	All lots	September  17, 2019
Sanis Health Inc.	Ranitidine	02353016	150 mg	All lots	September 25, 2019
Sanis Health Inc.	Ranitidine	02353024	300 mg	All lots	September 25, 2019
Sivem Pharmaceuticals ULC	Ranitidine	02385953	150 mg	NP4179 NP4183 NP4184 NP5656 NP5657 NT2721 NT2722 NT2724 NT2757 NT2762 NT2763 NT2764 NT2765 PJ2434 PJ2435 PV6243 PV6244 PV6245	September 25, 2019
Sivem Pharmaceuticals ULC	Ranitidine	02385961	300 mg	NP4177 NP4180 NT1365 PX8854	September 25, 2019

What consumers should do

• Talk to your doctor or pharmacist at your earliest convenience about alternative, non-ranitidine treatment options appropriate for your health circumstances. There are many prescription and over-the-counter drug alternatives in Canada that are authorized for the same or similar uses as ranitidine.
• Individuals taking a prescription ranitidine 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 ranitidine product and you have concerns about your health.
• Report any health product adverse events or complaints to Health Canada.

Canadians with questions about the recalls can contact

• Apotex Inc. via Stericycle Inc. at 1-877-574-5043
• Pro Doc Limitée at 1-800-361-8559, or by e-mail at [email protected]
• Sandoz Canada at 1-800-361-3062
• Sanis Health Inc. at 1-866-236-4076
• Sivem Pharmaceuticals ULC at 1-855-757-4836

Related links:

• Health Canada assessing NDMA in ranitidine (2019-09-13)
• Apotex Inc. ranitidine recall (2019-09-24)

Également disponible en français

SOURCE Health Canada

For further information: Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709