Ranitidine products recalled because of a nitrosamine impurity - MegaMejor

UPDATE: March 11, 2022 – Pharmascience Inc. recollects 30 numerous 150 mg over-the-counter ranitidine packaged in blister packs

Pharmascience Inc. is recalling 30 numerous over-the-counter ranitidine medication (150 mg tablets), packaged in blister packs, after exams discovered NDMA, a nitrosamine impurity, above the appropriate stage in some heaps. The merchandise are offered below numerous personal labels. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE – December 3, 2021 – Pharmascience Inc. recollects sure numerous over-the-counter ranitidine

Pharmascience Inc. is recalling 18 numerous over-the-counter ranitidine medication (75 mg and 150 mg tablets) after exams discovered NDMA, a nitrosamine impurity, near and above the appropriate stage. The merchandise are offered below numerous personal labels. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: February 5, 2021 – Pharmascience Inc. recollects sure numerous prescription and over-the-counter ranitidine as a precaution

Pharmascience Inc. is recalling 13 numerous prescription and over-the-counter ranitidine medication (150 mg tablets) after exams discovered NDMA, a nitrosamine impurity, at beneath however near the accepted stage. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: January 30, 2021 – Pharmascience Inc. recollects further numerous over-the-counter ranitidine

Trending: Is Zantac Back on the Market?

Pharmascience Inc. is recalling 23 further numerous its over-the-counter ranitidine medication (75 mg tablets) after exams discovered NDMA, a nitrosamine impurity, above accepted ranges. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: January 8, 2021 – Pharmascience Inc. recollects sure numerous over-the-counter ranitidine

Pharmascience Inc. is recalling 13 further numerous its store-brand over-the-counter ranitidine merchandise (75 mg energy pill) after exams discovered NDMA, a nitrosamine impurity, above accepted ranges. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: August 31, 2020 – Pharmascience Inc. recollects one lot of PMS-Ranitidine as a precaution

Pharmascience Inc. is recalling one lot of prescription PMS-Ranitidine (150 mg energy pill) as a precaution after exams discovered NDMA, a nitrosamine impurity, at near the accepted stage. Please seek advice from the Affected Merchandise desk for detailed data on the recalled lot (lot 619003).

Well being Canada lately offered an replace on the standing of ranitidine medication in Canada. Corporations wishing to renew gross sales have been permitted to take action offered they check each batch of ranitidine product earlier than releasing it and proceed to recurrently retest the batch all through its shelf life, to reveal that merchandise don’t comprise increased than accepted ranges of NDMA.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: October 30, 2019 – Ranbaxy Prescribed drugs Canada Inc. recollects prescription ranitidine merchandise as a precaution; request to cease distribution stays in place whereas Well being Canada continues to evaluate NDMA

Ranbaxy Prescribed drugs Canada Inc. is recalling all numerous its prescription ranitidine merchandise from the Canadian market as a precautionary measure. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: October 25, 2019 – Further ranitidine merchandise recalled as a precautionary measure; request to cease distribution stays in place whereas Well being Canada continues to evaluate NDMA

Dominion Pharmacal, Laboratoire Riva Inc., Pharmascience Inc. and Vita Well being Inc. are recalling all numerous their prescription and over-the-counter ranitidine merchandise from the Canadian market as a precautionary measure. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: October 18, 2019 – Further ranitidine merchandise recalled, together with Zantac; request to cease distribution stays in place whereas Well being Canada continues to evaluate NDMA

Further prescription and over-the-counter ranitidine medication, together with Zantac, are being recalled by Sanofi Client Well being Inc., Sivem Prescribed drugs ULC and Teva Canada Restricted as a result of they might comprise the impurity N-nitrosodimethylamine (NDMA) above acceptable ranges. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

UPDATE: September 25, 2019 – Well being Canada requests that firms cease distributing ranitidine medication in Canada whereas it assesses NDMA; further merchandise being recalled

Further ranitidine medication are being recalled by 4 firms: Apotex Inc., Professional Doc Limitée, Sanis Well being Inc., and Sivem Prescribed drugs ULC. The heaps are being recalled as they might have been manufactured utilizing an lively pharmaceutical ingredient containing an impurity, N-nitrosodimethylamine (NDMA), above acceptable ranges. Please seek advice from the Affected Merchandise desk for detailed data on the recalled heaps.

Ought to any further recollects be needed, Well being Canada will replace the desk and inform Canadians.

Authentic Info Replace: September 17, 2019 – Well being Canada requests that firms cease distributing ranitidine medication in Canada whereas it assesses NDMA; some merchandise being recalled

OTTAWA – Well being Canada lately knowledgeable Canadians that it’s assessing the difficulty of an impurity referred to as N-nitrosodimethylamine (NDMA) detected in some ranitidine medication. Present proof means that NDMA could also be current in ranitidine, whatever the producer. Consequently, and at Well being Canada’s request, firms advertising ranitidine merchandise in Canada have stopped any additional distribution till proof is offered to reveal that they don’t comprise NDMA above acceptable ranges.

The request to cease distribution signifies that the prevailing inventory of ranitidine merchandise presently accessible in pharmacies or at retail shops could proceed to be offered. That is totally different from a recall, since merchandise which can be being recalled can now not be offered.

That is an interim, precautionary measure as Well being Canada continues to assemble data from firms and to evaluate the difficulty with different worldwide regulators.

One firm, Sandoz Canada, is recalling its oral prescription merchandise in Canada and different nations after testing recognized ranges of NDMA above what is taken into account acceptable if the drug had been to be taken over a lifetime. Ought to any further recollects be deemed needed, Well being Canada will replace the desk and inform Canadians.

Ranitidine is offered in Canada over-the-counter (for instance, below the model title Zantac and as generics) and by prescription (as generics). Over-the-counter ranitidine is authorised to stop and relieve heartburn related to acid indigestion and bitter abdomen. Prescription ranitidine medication are used to scale back abdomen acid for the therapy and prevention of varied situations, reminiscent of heartburn, ulcers of the abdomen and intestines, and gastroesophageal reflux illness (generally generally known as GERD).

NDMA is assessed as a possible human carcinogen, which implies long-term publicity to ranges above what is taken into account secure may enhance the danger of most cancers. We’re all uncovered to low ranges of NDMA in some meals (reminiscent of meats, dairy merchandise and greens) and in ingesting water. NDMA just isn’t anticipated to trigger hurt when ingested at very low ranges.

Well being Canada continues to assemble and share data with different regulators, together with the U.S. Meals and Drug Administration and the European Medicines Company, and with Canadian firms to higher perceive the difficulty and whether or not there could also be a danger to Canadians. This consists of conducting its personal exams and assessing whether or not the outcomes seen in laboratory exams current a human well being danger. The Division will take motion if a danger to Canadians is recognized, and can proceed to tell the general public of recent security data.

Well being Canada has been working to handle the difficulty of NDMA and comparable impurities, generally known as nitrosamines, present in sure “sartan” angiotensin receptor blocker (ARB) blood stress drugs since 2018. Well being Canada continues to work intently with worldwide regulatory companions to handle the difficulty. This consists of broadening its efforts to judge the potential for nitrosamines in medication apart from sartans and measures to handle and forestall the impurities.

Who’s affected

Customers and sufferers who’re taking a ranitidine drug.

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Source: https://recalls-rappels.canada.ca/en/alert-recall/ranitidine-products-recalled-because-nitrosamine-impurity

Who’s affected

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