Precautionary pharmacy and retail level recall of several batches of a number of Ranitidine medicines in Ireland

Notice type: Recall

Date: 23/09/2019

Pharmacists, wholesalers and retailers which stock medicinal products for general sale.

The Health Products Regulatory Authority wishes to advise that, as a precautionary measure, several batches of a number of ranitidine products on the Irish market are being recalled to pharmacy and retail level in Ireland. The reason for the recall is that a nitrosamine impurity has been identified in ranitidine active substance batches manufactured at a manufacturing site in India. 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 / retail level recall is being undertaken as a precautionary measure.

All batches listed in Appendix 1 were manufactured using ranitidine active substance from that manufacturing plant.

Recall letters are being issued by the marketing authorisation holders listed in Appendix 1 to affected wholesalers, pharmacies and retailers.

Update: Please note that a second related ranitidine recall took place on 2 October 2019. See below link for additional details.

Further precautionary recall of all in-date batches of Zantac 150mg film-coated tablets

Specific Information for Pharmacists and Retailers:

1. Immediately quarantine any units from the products listed in Appendix 1 which you have in your pharmacy or retail outlet. For hospital pharmacies, this includes wards, clinics and any other relevant locations within your hospital.
2. Hospital pharmacists are requested to inform relevant prescribers within their hospital of this recall action.
3. 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.

Specific Information for Wholesalers:

1. Please immediately quarantine any units from the above referenced batches which you have in your possession.
2. The wholesaler which supplied you will provide instruction on how to return stock.

Not all ranitidine-containing medicines are affected by the recall.

Appendix 1 - List of Ranitidine batches being recalled to pharmacy and retail level. 

(Download list: Appendix 1 Ranitidine batch listing 230919)

For the five products placed on the market by GlaxoSmithKline and Chefaro’s Zantac 75 mg Film-coated Tablet product, not all batches on the Irish market are subject to this recall. Other batches of those products which are available on the Irish market were manufactured using an alternative source of API.

Expiry dates for Chefaro Ireland’s Zantac 75mg Film-coated Tablets batches will be provided in the company’s recall letter.