Analysis of information sources in references of the Wikipedia article "Ranitidine" in English language version.
FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.This article incorporates text from this source, which is in the public domain.
FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA's LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.
Today, we are announcing that we have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use.This article incorporates text from this source, which is in the public domain.
Novartis on Wednesday said it was stopping worldwide distribution of its generic versions of the antacid while regulators investigate the fact that the impurity NDMA has been detected in these ranitidine-based drugs.
GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
The MHRA has issued an alert to healthcare professionals, as GlaxoSmithKline is recalling all unexpired stock of four types of Zantac, the medicine used to treat conditions such as heartburn and stomach ulcers.
Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.
Teva UK Ltd is recalling unexpired stock of certain batches of 2 types of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.
Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.
Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
The MHRA has issued alerts to healthcare professionals and retailers, as Perrigo Company plc is recalling all unexpired stock of certain batches of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.
Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.
Ranitidine – MHRA drug alert issued as Creo Pharma Limited and Tillomed Laboratories recall unexpired stock.
OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
A drug alert has been issued to retailers and healthcare professionals as 4 companies are recalling batches of certain over-the-counter Ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
All oral formulations of ranitidine are shortly anticipated to be out of stock until further notice. This alert provides healthcare professionals with advice on the management of patients currently taking ranitidine.
ranitidine formed millions of nanograms of NDMA [per tablet]
Valisure discovered the link of Zantac and its generics to the carcinogen NDMA during its routine testing of every batch of every medication, and first notified the FDA of its initial findings in June of 2019
FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.This article incorporates text from this source, which is in the public domain.
FDA recommends using an LC-HRMS testing protocol to test samples of ranitidine. FDA's LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory. International regulators using similar LC-MS testing methods have also shown the presence of low levels of NDMA in ranitidine samples.
Novartis on Wednesday said it was stopping worldwide distribution of its generic versions of the antacid while regulators investigate the fact that the impurity NDMA has been detected in these ranitidine-based drugs.
Today, we are announcing that we have asked manufacturers of ranitidine and nizatidine products to expand their testing for NDMA to include all lots of the medication before making them available to consumers. If testing shows NDMA above the acceptable daily intake limit (96 nanograms per day or 0.32 parts per million for ranitidine), the manufacturer must inform the agency and should not release the lot for consumer use.This article incorporates text from this source, which is in the public domain.
GlaxoSmithKline, trading as Glaxo Welcome Ltd, is recalling all unexpired stock of Zantac (ranitidine hydrochloride) prescription only medicines (POM) from pharmacies.
The MHRA has issued an alert to healthcare professionals, as GlaxoSmithKline is recalling all unexpired stock of four types of Zantac, the medicine used to treat conditions such as heartburn and stomach ulcers.
Teva UK Limited trading as ratiopharm GmbH is recalling all unexpired stock of Ranitidine Effervescent Tablets from pharmacies.
Teva UK Ltd is recalling unexpired stock of certain batches of 2 types of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.
Rosemont Pharmaceuticals Limited is recalling unexpired stock from pharmacies as a precautionary measure due to possible contamination with an impurity.
Omega Pharma Limited and Galpharm International Limited are recalling unexpired stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
The MHRA has issued alerts to healthcare professionals and retailers, as Perrigo Company plc is recalling all unexpired stock of certain batches of Ranitidine medicines used to treat conditions such as heartburn and stomach ulcers.
Creo Pharma Limited and Tillomed Laboratories Limited are recalling all unexpired stock of the products listed in this alert.
Ranitidine – MHRA drug alert issued as Creo Pharma Limited and Tillomed Laboratories recall unexpired stock.
OTC Concepts Ltd, Relonchem Ltd, Noumed Life Sciences Ltd and Medreich Plc. are recalling stock from pharmacies and retail stores as a precautionary measure due to possible contamination with an impurity.
A drug alert has been issued to retailers and healthcare professionals as 4 companies are recalling batches of certain over-the-counter Ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
Accord Healthcare are recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
Medley Pharma Limited is recalling all unexpired stock of the below products from pharmacies and retail stores as a precautionary measure.
Medreich Plc is recalling all unexpired stock of the above products from pharmacies and wholesalers as a precautionary measure due to possible contamination with an impurity N-nitrosodimethylamine (NDMA) which has genotoxic and carcinogenic potential.
All oral formulations of ranitidine are shortly anticipated to be out of stock until further notice. This alert provides healthcare professionals with advice on the management of patients currently taking ranitidine.