Health CanadaGeneral Alert

Ranitidine products recalled because of a nitrosamine impurity

Publié le: 11 mars 2022ID du rappel: 59609Catégorie: Produits de ConsommationPays: Canada
Canada
Safety AlertHealth CanadaCanadaCanada

Ranitidine products recalled because of a nitrosamine impurity

Recalling Firm: Communications and Public Affairs Branch

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Motif du rappel / Danger

Product safety

Description du produit & Identification

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 contactApotex 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.comSandoz 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)Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs (2019-12-02)Status of ranitidine drugs in Canada (2020-07-23)

Produits concernés

Over-the-counter and prescription ranitidine drugs (LATEST UPDATE: March 11, 2022 – Pharmascience Inc. recall)

Additional Source Details

FieldValue
N I D59609
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/ranitidine-products-recalled-because-nitrosamine-impurity
IssueProduct safety
Title Ranitidine products recalled because of a nitrosamine impurity
ProductOver-the-counter and prescription ranitidine drugs (LATEST UPDATE: March 11, 2022 – Pharmascience Inc. recall)
Archived0
CategoryHealth products
Last updated2022-03-11
OrganizationCommunications and Public Affairs Branch
What you should doTalk 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 contactApotex 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.comSandoz 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)Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs (2019-12-02)Status of ranitidine drugs in Canada (2020-07-23)

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Health Canada).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Ranitidine products recalled because of a nitrosamine impurity?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Health Canada). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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  • Entreprise responsableCommunications and Public Affairs Branch
Recall Hazard Severity
Caution (Class III)
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