Ranitidine products recalled because of a nitrosamine impurity

Issue

UPDATE: March 11, 2022 – Pharmascience Inc. recalls 30 lots of 150 mg over-the-counter ranitidine packaged in blister packs Pharmascience Inc. is recalling 30 lots of over-the-counter ranitidine drugs (150 mg tablets), packaged in blister packs, after tests found NDMA, a nitrosamine impurity, above the acceptable level in some lots. The products are sold under various private labels. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE - December 3, 2021 - Pharmascience Inc. recalls certain lots of over-the-counter ranitidine Pharmascience Inc. is recalling 18 lots of over-the-counter ranitidine drugs (75 mg and 150 mg tablets) after tests found NDMA, a nitrosamine impurity, close to and above the acceptable level. The products are sold under various private labels. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: February 5, 2021 - Pharmascience Inc. recalls certain lots of prescription and over-the-counter ranitidine as a precaution Pharmascience Inc. is recalling 13 lots of prescription and over-the-counter ranitidine drugs (150 mg tablets) after tests found NDMA, a nitrosamine impurity, at below but close to the accepted level. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: January 30, 2021 - Pharmascience Inc. recalls additional lots of over-the-counter ranitidine Pharmascience Inc. is recalling 23 additional lots of its over-the-counter ranitidine drugs (75 mg tablets) after tests found NDMA, a nitrosamine impurity, above accepted levels. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: January 8, 2021 - Pharmascience Inc. recalls certain lots of over-the-counter ranitidine Pharmascience Inc. is recalling 13 additional lots of its store-brand over-the-counter ranitidine products (75 mg strength tablet) after tests found NDMA, a nitrosamine impurity, above accepted levels. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: August 31, 2020 - Pharmascience Inc. recalls one lot of PMS-Ranitidine as a precaution Pharmascience Inc. is recalling one lot of prescription PMS-Ranitidine (150 mg strength tablet) as a precaution after tests found NDMA, a nitrosamine impurity, at close to the accepted level. Please refer to the Affected Products table for detailed information on the recalled lot (lot 619003). Health Canada recently provided an update on the status of ranitidine drugs in Canada. Companies wishing to resume sales have been permitted to do so provided they test every batch of ranitidine product before releasing it and continue to regularly retest the batch throughout its shelf life, to demonstrate that products do not contain higher than accepted levels of NDMA. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: October 30, 2019 - Ranbaxy Pharmaceuticals Canada Inc. recalls prescription ranitidine products as a precaution; request to stop distribution remains in place while Health Canada continues to assess NDMA Ranbaxy Pharmaceuticals Canada Inc. is recalling all lots of its prescription ranitidine products from the Canadian market as a precautionary measure. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: October 25, 2019 - Additional ranitidine products recalled as a precautionary measure; request to stop distribution remains in place while Health Canada continues to assess NDMA Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc. and Vita Health Inc. are recalling all lots of their prescription and over-the-counter ranitidine products from the Canadian market as a precautionary measure. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: October 18, 2019 - Additional ranitidine products recalled, including Zantac; request to stop distribution remains in place while Health Canada continues to assess NDMA Additional prescription and over-the-counter ranitidine drugs, including Zantac, are being recalled by Sanofi Consumer Health Inc., Sivem Pharmaceuticals ULC and Teva Canada Limited because they may contain the impurity N-nitrosodimethylamine (NDMA) above acceptable levels. Please refer to the Affected Products table for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. UPDATE: September 25, 2019 - Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; additional products being recalled 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 for detailed information on the recalled lots. Should any additional recalls be necessary, Health Canada will update the table and inform Canadians. Original Information Update: September 17, 2019 - Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled OTTAWA - 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. 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 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.

What you 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.
• Apotex Inc. via Stericycle Inc. at 1-877-574-5043;
• Dominion Pharmacal at 1-888-550-6060, or by e-mail at med.info@pharmascience.com;
• Laboratoire Riva Inc. at 1-450-434-7482, or by e-mail at jlavoie@labriva.com;
• Pro Doc Limitée at 1-800-361-8559, or by e-mail at medinfo@prodoc.qc.ca;
• Ranbaxy Pharmaceuticals Canada Inc. at 1-866-840-1340, or by e-mail at canadacustomerservice@sunpharma.com
• Sandoz Canada at 1-800-361-3062;
• Sanis Health Inc. at 1-866-236-4076;
• Sanofi Consumer Health Inc. at 1-800-636-3664 or by email at Ch.canada-ConsumerCare@sanofi.com;
• Sivem Pharmaceuticals ULC at 1-855-757-4836;
• Pharmascience Inc. at 1-888-550-6060, or by email at med.info@pharmascience.com;
• Teva Canada Limited at 1-800-268-4129;
• Vita Health Products Inc. at 1-877-637-7557.
• Health Canada assessing NDMA in ranitidine (2019-09-13)
• Apotex Inc. ranitidine recall (2019-09-24)
• Sanofi Consumer Health Inc. Zantac recall (2019-10-18)
• Pharmascience Inc. ranitidine recall (2019-10-25)