What began as an independent investigation by online pharmacy, Valisure, has now extended to a global recall of various ranitidine-based medicines.
Adding to previous recalls initiated in the US and Canada, which has seen Sandoz pull all its ranitidine hydrochloride capsules from the US market, health authorities in South Korea and India have also asked companies to take action.
According to local media reports, this has led GSK to issue a voluntary recall of Zinetac 150mg and 300mg tablets from the Indian market.
A harder line approach was taken by authorities in South Korea, where the Ministry of Food and Drug Safety prohibited the sale of ranitidine-based medicines, again reported by local media, after testing revealed that N-nitrosodimethylamine (NDMA) was present in products at levels deemed unsafe.
In addition, Health Canada announced that four companies, Apotex, Pro Doc, Sanis Health, and Sivem Pharmaceuticals, would be recalling batches of medicine due to the active pharmaceutical ingredient (API) containing NDMA.
This action follows on from Health Canada requesting companies stop further distribution of the products until evidence could be provided that relevant medicine do not contain any impurities.
In the US, Apotex has also followed suit with Sandoz by issuing a voluntary nationwide recall of ranitidine 75mg and 150mg tablets of all pack sizes and formats to the retail level, adding to the Canadian recall
Ranitidine tablets are widely used, over the counter products for the treatment of gastrointestinal conditions, such as heartburn and acid indigestion.
