PHARMANIAGA BRAND RANITIDINE TABLET RECALL IN MALAYSIA AND THE CURRENT STATUS IN BRUNEI DARUSSALAM
The Ministry of Health would like to notify members of the public with regards to the Pharmaniaga brand of Ranitidine tablet in Brunei Darussalam. This is with respect to the recent information disseminated through social media with regards to the recall of the product which was found to contain the impurity, N-nitrosodimethylamine (NDMA) that was above internationally accepted levels. This recall was initiated in Malaysia for the Malaysian market only.
The Pharmaniaga brand of Ranitidine is NOT used by the Ministry of Health, Brunei Darussalam. It has also been verified that the said product is no longer available for use in the Brunei Darussalam market, and has been voluntarily recalled by the Product Licence Holder.
Ranitidine belongs to the class of medicines called H2-antagonists, which is used to reduce gastric acid, to treat indigestion and to treat various gastrointestinal disorders. It is a prescription only medicine in Brunei Darussalam.
Any patients who had supplies of the Pharmaniaga brand of Ranitidine tablet are advised not to stop their treatment and to consult with their doctor at the nearest hospital or health centres if they have any concerns.
The Ministry of Health, Brunei Darussalam has been closely and continuously monitoring the global ranitidine situation. The safety of the public is of the highest concern for the Ministry of Health. Timely and continuous safety and quality review are undertaken to ensure that the medicines are of quality, safe and efficacious for use in Brunei Darussalam.
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Reference : KK/PR/3
Date : 31 October 2019 / 3 Rabiulawal 1441H