Stormy Ranitidine Case in Pharmacy Sector

By Editorial Team 09/10/2019
Summary

PT Phapros Tbk (PEHA) withdrew and stopped the production of its products containing ranitidine active ingredients this week. This action was taken after receiving an official letter from the Indonesia Food and Drug Monitoring Agency (BPOM) for the withdrawal of ranitidine products from the market because it contains N-Nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

PEHA’s management said the recall is carried out by reaching out to all outlets throughout Indonesia, such as pharmacies, hospitals, health Centers, clinics, and doctors. This issue is happening after the US Food and Drug Administration and the European Medicine Agency (EMA) issued warning statements about NDMA in some ranitidine medicines on September 13, 2019.

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