The Food and Drug Authority decided to withdraw the preparation and suspend the registration of preparations containing ranitidine as a precaution for possible impurities of N-Nitrosodimethylamine (NDMA) classified as a potentially carcinogen. This comes after the authority monitored reports from international control bodies indicating the possibility of impurities in quantities

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Few N-Nitrosodimethylamine (NDMA) in some preparations containing ranitidine including Zantac®.

The "Food and Drug Administration" indicated that it studied the reasons for the possible emergence of these impurities to take the necessary measures that guarantee the safety and safety of marketed preparations containing "ranitidine", and after reviewing the report of the company (GLAXO SAUDI ARABIA) it was found that the source of the raw materials used in the manufacture of the preparation is one of the reasons The appearance of impurities,

Accordingly, it was decided to suspend and withdraw the preparation below, with all its registered pharmaceutical concentrations and forms:

ZANTAC®

GLAXO SAUDI ARABIA

In view of the different sources of materials used in the manufacture of these products between countries, the Commission suspended the registration of a number of precautionary measures until the results of laboratory analyzes. The Commission took samples from all the products marketed below that contain ranitidine for analysis and to ensure that the impurities in them do not exceed the permissible limit:

NADINE ®

PHARMA INTERNATIONAL CO.

RANACID®

TABUK PHARMACEUTICAL MANUFACTURING CO.

RANID®

TABUK PHARMACEUTICAL MANUFACTURING CO.

RANIMAX®

JAZEERA PHARMACEUTICAL INDUSTRIES (JPI)

ZYDAC®

JAMJOOM PHARMACEUTICALS COMPANY

The authority indicated that there are therapeutic natives that can be used after referring to the attending physician, calling on the community and health practitioners to inform the National Vigilance Center when any side effects of the drugs occur through the toll-free number: 8002490000, or the fax: 00966112057662, or the unified number: 19999, or the e-mail: npc.drug@sfda.gov.sa, or link: https://ade.sfda.gov.sa

Source: The Food and Drug Authority website