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

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

Last updated:

UPDATE: October 30, 2019

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:
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
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 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 00740748 150 mg All lots September 25, 2019
Pro Doc Limitée Ranitidine - 300 00740756 300 mg All lots September 25, 2019
*NEW* Ranbaxy Pharmaceuticals Canada Inc. Ran-Ranitidine 02336480 150 mg All lots October 30, 2019
*NEW* 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.
  • 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

Related links:

Advisory

Media enquiries

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

Public enquiries

(613) 957-2991
1-866 225-0709

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