Information Update - 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

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, Oct. 30, 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.

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 30mg                                                                     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*          
     Ran-Ranitidine                                                                                 02336480 
     150 mg             
      All lots     
     October 30, 2019



        Ranbaxy Pharmaceuticals
         Canada Inc.

    ---


       
              *NEW*          
     Ran-Ranitidine                                                                                 02336502 
     300 mg             
      All lots     
     October 30, 2019



        Ranbaxy Pharmaceuticals
         Canada Inc.

    ---


       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       
     September 25, 2019

                                                                                                                                                                
      NP4183

                                                                                                                                                                
      NP4184

                                                                                                                                                                
      NP5656

                                                                                                                                                                
      NP5657

                                                                                                                                                                
      NT2721

                                                                                                                                                                
      NT2722

                                                                                                                                                                
      NT2724

                                                                                                                                                                
      NT2757

                                                                                                                                                                
      NT2762

                                                                                                                                                                
      NT2763

                                                                                                                                                                
      NT2764

                                                                                                                                                                
      NT2765

                                                                                                                                                                
      PJ2434

                                                                                                                                                                
      PJ2435

                                                                                                                                                                
      PV6243

                                                                                                                                                                
      PV6244

                                                                                                                                                                
      PV6245

    ---

        K46484                    
     October 18, 2019

        K46485

        K48440

        K48679

        K50204

        K50206

        K50207

        K50590

        K50594

        K50677

        K50908

        K50925

        K50928

        K50932

        K50935

        K51080

    ---

        Sivem Pharmaceuticals ULC 
     Ranitidine                                                                                     02385961 
     300 mg             
      NP4177       
     September 25, 2019

                                                                                                                                                                
      NP4180

                                                                                                                                                                
      NT1365

                                                                                                                                                                
      PX8854

    ---

        K50624                    
     October 18, 2019

        K50941

        K50947

        K50950

    ---

        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

    --  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

Related links:

    --  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)
    --  Vita Health Products Inc. ranitidine recall (2019-10-25)

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SOURCE Health Canada