Information Update - Ranitidine products recalled because of a nitrosamine impurity

UPDATE: Pharmascience Inc. recalls one lot of PMS-Ranitidine as a precaution

OTTAWA, Aug. 31, 2020 /CNW/ - 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, 2019Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled
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 30 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 mg

02247814

150 mg

All lots

October 25, 2019

Laboratoire Riva Inc.

Riva-Ranitidine 300 mg

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.
  • 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:

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SOURCE Health Canada

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