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The EMA has released an update on nitrosamines in drugs, saying that work is continuing to prevent and manage these impurities.
Ranitidine tablets have been recalled due to the possibility of the products containing unacceptable levels of NDMA.
Medreich Plc is recalling a number of ranitidine products due to possible contamination with an impurity N-nitrosodimethylamine (NDMA).
Mylan, Appco Pharma and Denton Pharma are voluntarily recalling nizatidine and ranitidine products due to potential unacceptable levels of NDMA.
The UK MHRA has issued a recall of two ranitidine products from Medley Pharma as a precautionary measure due to possible contamination.
This article highlights the 10 most popular news stories published by European Pharmaceutical Review in 2019.
To further its investigation into the cause of the NDMA impurities found in ranitidine and nizatidine, the FDA has asked manufacturers of these products to expand their testing to include all lots of the medication.
Four companies are recalling batches of certain over-the-counter ranitidine medicines used to treat conditions such as stomach ulcers and heartburn.
The FDA has announced that Precision Dose Inc is voluntarily recalling five lots of its ranitidine oral solution in the US.
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
The FDA has issued a statement on the results from ranitidine medication testing for nitrosamines, saying that they contain no more NDMA than smoked meats.
The UK healthcare agency has issued an alert for Perrigo ranitidine products, recalling and quarantining certain batches.
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.