GSK, the marketing authorisation holder for a number of presentations of Zantac (contains ranitidine), has on a voluntary and precautionary basis, extended the recall to the remainder of its tablet products. A ranitidine product, parallel imported by Imbat Ltd., is also included in the recall. The recall will go to pharmacy level. Please see details below.
At the request of the HPRA, no additional batches of the intravenous (IV) and syrup presentations of Zantac have been included in this second recall at this time. This is on the basis that there is no evidence that the NDMA impurity has caused any harm to patients, the lack of available suitable authorised alternatives to these prescribed medicines, and the need to maintain supply for paediatric and other patients who may require IV or syrup products. The HPRA is working with the HSE to identify, where possible and appropriate, suitable alternatives.
The HPRA states that this is an evolving issue and it is possible that a recall by GSK of the Zantac IV and/or syrup product batches may be required from the Irish market at a later date. An update in relation to these presentations will be provided in the coming days.
Details of the extension to the recall are set out below.
Problem Or Issue:
The HPRA wishes to advise that, as a precautionary measure, all in-date batches of Zantac 150 mg Film-coated Tablets are being recalled to pharmacy level in Ireland. The reason for the recall is that a nitrosamine impurity has been identified in ranitidine active substance batches used in the manufacture of these tablets. This impurity, N-Nitroso dimethylamine (NDMA), is classified as a probable human carcinogen based on results from laboratory tests. It is a known environmental contaminant and found in water and foods.
At present, there is no evidence that this impurity has caused any harm to patients and therefore this pharmacy level recall is being undertaken as a precautionary measure.
Recall letters are being issued by the marketing authorisation holders listed in Table 1 to affected wholesalers and pharmacies.
Actions To Be Taken:
Specific Information for Pharmacists:
- Immediately quarantine any units from the products listed in Table 1 which you have in your pharmacy. For hospital pharmacies, this includes wards, clinics and any other relevant locations within your hospital.
- Hospital pharmacists are requested to inform relevant prescribers within their hospital of this recall action.
- Return the quarantined units to your wholesaler within the following 14 days. Your wholesaler will be in a position to advise you about receiving credit for the packs that you return.
There is no requirement to contact patients, as this is a pharmacy / retail level recall.
See also the GSK pharmacy recall letter above linked above.
Specific Information for Wholesalers:
- Please immediately quarantine any units from the products listed in Table 1 which you have in your possession.
- The wholesaler which supplied you will provide instruction on how to return stock.
See also the GSK wholesaler recall letter above linked above.