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

Notice type: Recall

Date: 02/10/2019

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.



Product name or type:
Refer to Table 1 below


Reference:
QDR-H-19-653 and QDR-H-19-655


Authorisation Number:
Refer to Table 1 below


Active Substance:
Ranitidine hydrochloride


Product Classification:
Products subject to prescription. Refer to Table 1 below.


Serial Or Batch Number And Expiry Date:
All in-date batches


Prescription Required:
Yes


Target Audience:
Pharmacists and Wholesalers


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.



Background Information Or Related Documents:

GSK Letter to Healthcare Professionals - Prescribers and Pharmacists (dated 3 October)

Pharmacy Recall Letter (posted by GSK on 3 October 2019)

Wholesaler Recall Letter (posted by GSK on 3 October 2019)

Initial recall of other batches of Ranitidine medicines on 23 September 2019.


Actions To Be Taken:

Specific Information for Pharmacists:

  1. 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.
  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.

See also the GSK pharmacy recall letter above linked above.


Specific Information for Wholesalers:

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

See also the GSK wholesaler recall letter above linked above.



Further Information:
Table 1:

 

Product Name

PA / PPA Number

Batch number (BN) and expiry date

Marketing Authorisation Holder Name

Method of Sale or Supply

1

Zantac 150 milligram(s) Film-coated Tablets

PA1077/13/3

All in-date batches

Glaxo SmithKline (Ireland) Ltd.

Product subject to prescription

2

Zantac 150 milligram(s) Film-coated Tablets

PPA1151/9/1

All in-date batches

Imbat Ltd.

Product subject to prescription



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