The South African Health Products Regulatory Authority (SAHPRA), in collaboration with other regulatory agencies, are reviewing all ranitidine-containing medicines with the following Active Pharmaceutical Ingredient; ranitidine. SAHPRA previously issued a media release regarding the recall and quarantine of ranitidine containing medicines (29 October 2019 and...
The South African Health Products Regulatory Authority (SAHPRA) would like to update and reassure the public on the status of ranitidine-containing medicines in response to recent renewed concerns about contamination with N-nitrosodimethylamine (NDMA) impurities. NMDA is classified as a probable human carcinogen (substance that could...
The South African Health Products Regulatory Authority (SAHPRA) has learned about the safety concerns regarding the presence of a nitrosamine impurity called NDMA in ranitidine-containing medicines. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of...
