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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
Last updated:
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 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: 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 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: 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 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: 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.
| 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. | Compliments Maximum Strength Acid Reducer (50 tablets) | 02293471 | 150mg | 628453 | February 5, 2021 |
| Pharmascience Inc. | CO-OP CARE + Maximum Strength Acid Reducer (24 tablets) | 628308F | February 5, 2021 | ||
| Pharmascience Inc. | Life Brand Maximum Strength Acid Reducer (50 tablets) | 628429 | February 5, 2021 | ||
| Pharmascience Inc. | Life Brand Maximum Strength Acid Reducer (24 tablets) | 628308E | February 5, 2021 | ||
| Pharmascience Inc. | Option+ Maximum Strength Acid Reducer (8 tablets) | 628308B | February 5, 2021 | ||
| Pharmascience Inc. | Personnelle Maximum Strength Acid Reducer (50 tablets) | 628442 | February 5, 2021 | ||
| Pharmascience Inc. | PERSONNEL Maximum Strength Acid Reducer (8 tablets) |
628308A 628308C |
February 5, 2021 | ||
| Pharmascience Inc. | PERSONNEL Maximum Strength Acid Reducer (24 tablets) | 628308D | February 5, 2021 | ||
| Pharmascience Inc. | pms-RANITIDINE | 02242453 |
626718 623633 624871 626714 |
February 5, 2021 | |
| Pharmascience Inc. | pms-RANITIDINE | February 5, 2021 | |||
| Pharmascience Inc. | ATOMA Acid Reducer (10 tablets) | 02247551 | 75 mg | 621791O | January 30, 2021 |
| Pharmascience Inc. | ATOMA Acid Reducer (30 tablets) | 621791X | January 30, 2021 | ||
| Pharmascience Inc. | BIOMEDIC Acid Reducer (30 tablets) | 621791K | January 30, 2021 | ||
| Pharmascience Inc. | BIOMEDIC Acid Reducer (30 tablets) | 621791U | January 30, 2021 | ||
| Pharmascience Inc. | Compliments Acid Reducer (60 tablets) | 621791D | January 30, 2021 | ||
| Pharmascience Inc. | Life Brand Acid Reducer (10 tablets) | 621791G | January 30, 2021 | ||
| Pharmascience Inc. | Life Brand Acid Reducer (10 tablets) | 621791P | January 30, 2021 | ||
| Pharmascience Inc. | Life Brand Acid Reducer (30 tablets) | 621791Q | January 30, 2021 | ||
| Pharmascience Inc. | Life Brand Acid Reducer (60 tablets) | 621791AA | January 30, 2021 | ||
| Pharmascience Inc. | London Drugs Acid Reducer (30 tablets) | 621791R | January 30, 2021 | ||
| Pharmascience Inc. | OPTION+ Acid Reducer (10 tablets) | 621791H | January 30, 2021 | ||
| Pharmascience Inc. | OPTION+ Acid Reducer (10 tablets) | 621791T | January 30, 2021 | ||
| Pharmascience Inc. | OPTION+ Acid Reducer (40 tablets) | 621791Y | January 30, 2021 | ||
| Pharmascience Inc. | Personnelle Acid Reducer (10 tablets) | 621791A | January 30, 2021 | ||
| Pharmascience Inc. | Personnelle Acid Reducer (10 tablets) | 621791N | January 30, 2021 | ||
| Pharmascience Inc. | Personnelle Acid Reducer (40 tablets) | 621791I | January 30, 2021 | ||
| Pharmascience Inc. | Personnelle Acid Reducer (40 tablets) | 621791Z | January 30, 2021 | ||
| Pharmascience Inc. | PHARMASAVE Acid Reducer (30 tablets) | 621791V | January 30, 2021 | ||
| Pharmascience Inc. | Rexall Acid Reducer (60 tablets) | 621791S | January 30, 2021 | ||
| Pharmascience Inc. | Rexall Acid Reducer (10 tablets) | 621791F | January 30, 2021 | ||
| Pharmascience Inc. | Rexall Acid Reducer (10 tablets) | 621791M | January 30, 2021 | ||
| Pharmascience Inc. | Rexall Acid Reducer (30 tablets) | 621791E | January 30, 2021 | ||
| Pharmascience Inc. | Rexall Acid Reducer (30 tablets) | 621791W | January 30, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Compliments | 02247551 | 75 mg | 619254I | January 8, 2021 |
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name EXACT | 619254G | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name EXACT | 619254B | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Life Brand | 624735C | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Life Brand | 627539C | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Life Brand | 619254H | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Life Brand | 619254C | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name OPTION+ | 624735B | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name OPTION+ | 627539B | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Personnelle | 624735A | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Personnelle | 619254K | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name Personnelle | 627539A | January 8, 2021 | ||
| Pharmascience Inc. | Acid Reducer (raniditine) sold under the brand name PHARMASAVE | 619254J | January 8, 2021 | ||
| 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 |
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
- 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)
- 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)
Related AWRs
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