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, 2019 – Health 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

• Apotex Inc. via Stericycle Inc. at 1-877-574-5043
• Dominion Pharmacal at 1-888-550-6060, or by e-mail at [email protected]
• Laboratoire Riva Inc. at 1-450-434-7482, or by e-mail at [email protected]
• Pro Doc Limitée at 1-800-361-8559, or by e-mail at [email protected]
• Ranbaxy Pharmaceuticals Canada Inc. at 1-866-840-1340, or by e-mail at [email protected] 
• 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 [email protected]
• Sivem Pharmaceuticals ULC at 1-855-757-4836
• Pharmascience Inc. at 1-888-550-6060, or by email at [email protected]
• 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)

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SOURCE Health Canada

For further information: Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709