Ranitidine products recalled because of a nitrosamine impurity

Starting date: September 25, 2019 Type of communication: Information Update Subcategory: Drugs Source of recall: Health Canada Issue: Important Safety Information Audience: General Public Identification number: RA-71029

2020-08-31

Last updated:

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 below 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 below 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 below for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table below 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 below for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table below 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 below for detailed information on the recalled lots.

Should any additional recalls be necessary, Health Canada will update the table below 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 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 - 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 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. Please note that they are listed alphabetically by company: 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 150 mg 00733059 150 mg All lots September 25, 2019 Apotex Inc. Apo-Ranitidine Tablet 300 mg 00733067 300 mg All lots September 25, 2019 Dominion Pharmacal Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand name Personnelle 02407523 150 mg All lots October 25, 2019 Laboratoire Riva Inc. Riva-Ranitidine 150 02247814 150 mg All lots October 25, 2019 Laboratoire Riva Inc. Riva-Ranitidine 300 02247815 300 mg All lots October 25, 2019 Laboratoire Riva Inc. Acid Reducer (ranitidine) sold under the brand names Biomedic, Circle K and Option+ 02452464 75 mg All lots October 25, 2019 Pharmascience Inc. PMS-Ranitidine 150 mg 02242453 150 mg 619003 August 31, 2020 Pharmascience Inc. PMS-Ranitidine 150 mg 02242453 150 mg All lots October 25, 2019 Pharmascience Inc. PMS-Ranitidine 300 mg 02242454 300 mg Al lots October 25, 2019 Pharmascience Inc. Acid Reducer (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Exact, Life Brand, London Drugs, Option+, Personnelle, Pharmasave, Preferred Pharmacy, Rexall and Selection 02247551 75 mg All lots October 25, 2019 Pharmascience Inc. Maximum Strength Acid Reducer Without Prescription (ranitidine) sold under the brand names Atoma, Biomedic, Compliments, Co-op Care+, Equate, Exact, Health One, Kirkland Signature, London Drugs, Option+, Personnelle, Pharmasave, Rexall and Selection 02293471 150 mg All lots October 25, 2019 Pharmascience Inc. Acid Reducer (ranitidine) sold under the brand names Exact and Life Brand 02400103 150 mg All lots October 25, 2019 Pro Doc Limitée Ranitidine - 150 mg 00740748 150 mg All lots September 25, 2019 Pro Doc Limitée Ranitidine - 300 mg 00740756 300 mg All lots September 25, 2019 Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336480 150 mg All lots October 30, 2019 Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336502 300 mg All lots October 30, 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 Sanofi Consumer Health Inc. Zantac (ranitidine) 02230287 75 mg All lots October 18, 2019 Sanofi Consumer Health Inc. Zantac Maximum Strength Non-Prescription (ranitidine) 02277301 150 mg All lots October 18, 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 K46484

K46485

K48440

K48679

K50204

K50206

K50207

K50590

K50594

K50677

K50908

K50925

K50928

K50932

K50935

K51080 October 18, 2019 Sivem Pharmaceuticals ULC Ranitidine 02385961 300 mg NP4177

NP4180

NT1365

PX8854 September 25, 2019 K50624

K50941

K50947

K50950 October 18, 2019 Teva Canada Limited Act Ranitidine 02248570 150 mg All lots October 18, 2019 Teva Canada Limited Act Ranitidine 02248571 300 mg All lots October 18, 2019 Vita Health Products Inc. Acid Reducer (ranitidine) sold under the brand names Equate, iPharma, Stanley and Western Family 02298740 75 mg All lots October 25, 2019 Vita Health Products Inc. Maximum Strength Acid Reducer (ranitidine) sold under the brand names Equate, iPharma and Western Family 02298902 150 mg All lots October 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.

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;

via Stericycle Inc. at 1-877-574-5043; Dominion Pharmacal at 1-888-550-6060, or by e-mail at med.info@pharmascience.com;

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;

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;

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

at 1-866-840-1340, or by e-mail at canadacustomerservice@sunpharma.com Sandoz Canada at 1-800-361-3062;

at 1-800-361-3062; Sanis Health Inc. at 1-866-236-4076;

at 1-866-236-4076; Sanofi Consumer Health Inc. at 1-800-636-3664 or by email at Ch.canada-ConsumerCare@sanofi.com;

at 1-800-636-3664 or by email at Ch.canada-ConsumerCare@sanofi.com; Sivem Pharmaceuticals ULC at 1-855-757-4836;

at 1-855-757-4836; Pharmascience Inc. at 1-888-550-6060, or by email at med.info@pharmascience.com;

1-888-550-6060, or by email at med.info@pharmascience.com; Teva Canada Limited at 1-800-268-4129;

at 1-800-268-4129; Vita Health Products Inc. at 1-877-637-7557.

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