The marketing authorisation holder informed its customers on October 24, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).

The marketing authorisation holder informed its customers on October 22, 2019 that following out-of-specification results during manufacturing below mentioned batches are recalled as a precautionary measure.

The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).

The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed that "Zantac Brausetabletten" may contain an impurity called N-nitrosodimethylamine (NDMA).

The marketing authorisation holder informed its customers on September 26, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).

Information on NDMA contamination in ranitidine medicines and recalls

Measures at EU level At the request of the European Commission, the European Medicines Agency (EMA) has begun reviewing medicines containing ranitidine after investigations found contamination with N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen based on animal studies. It is also present in small amounts in some…

The marketing authorisation holder informed its customers on September 16, 2019 that a review of ranitidine medicines after tests showed an impurity called N-nitrosodimethylamine (NDMA).

The marketing authorisation holder informed its customers on September 13, 2019 that below mentioned batch is recalled because of a incorrect package leaflet.

The marketing authorisation holder informed its customers on August 23, 2019 that below mentioned batch is recalled because the content of the active substance is below specification limits.