HPRA 因可能存在片剂混装召回 Warfant 3mg 片剂批号 25002（PA0073/139/002）

17/08/2026

Medicines for human use Recall

We wish to advise you that batch no. 25002 of Warfant 3mg Tablets, PA 0073/139/002 is being recalled with immediate effect.

Impacted units of the batch are being recalled from patient level. 

The impacted batch is being recalled due to a potential product mix up issue, whereby a report was received in which one sealed unit labelled as Warfant 3mg Tablets was found to contain Warfant 1 mg Tablets; all tablets within the container were the 1 mg presentation. One product mix-up report has been received to date, and it is considered that the rate of this defect is low within the batch.

The correct Warfant 3mg Tablets are blue in colour and are marked with ‘W3’ on one side. The Warfant 1 mg Tablets are brown in colour and are marked with the ‘W1’ on one side.

The recall letters (to pharmacists/healthcare professionals and wholesalers) and Dear Doctor Letter (DDL) can be found in the Documents section at the bottom of this page.

Product information

Product name

Warfant 3mg Tablets

Active substance

WARFARIN SODIUM

Authorisation holder

Mercury Pharmaceuticals (Ireland) Ltd

Authorisation number

PA0073/139/002

Serial or batch number and expiry date

Batch no. 25002 of Warfant 3mg Tablets, expiry 03/2030

Human or veterinary medicine

Human Medicine

Target audience

Pharmacists, Healthcare Professionals, Wholesalers, Prescribers

Recall level

Patient level

Actions to be taken

Information for Pharmacists/Healthcare Professionals

Pharmacists/Healthcare Professionals are requested to perform the following actions:

1. For stock within your pharmacy or facility, immediately identify and quarantine any units (including partial units) of Warfant 3mg Tablets from batch no. 25002. For hospital pharmacies, clinics, nursing homes and other such facilities, this includes units at wards, clinics and any other relevant locations within your facility.
2. For Warfant 3mg Tablets which you have dispensed since 02/02/2026:
   • Check your dispensing records to identify any patients to whom Warfant 3mg Tablets were dispensed since 02/02/2026.
   • Contact those patients or their carers via telephone to request them to check that Warfant 3mg Tablets within their possession are the correct strength. The correct Warfant 3mg Tablets are blue in colour and are marked with ‘W3’ on one side. The incorrect Warfant 1 mg Tablets are brown in colour and are marked with the ‘W1’ on one side.
   • If any 1mg tablets present within a container labelled as 3mg are identified at patient level, advise the patient or their carer not to use the tablets, and to return the container to the pharmacy at their earliest opportunity, where they will obtain a replacement. Quarantine any units returned by your customers and notify Advanz Pharma of any patient returns via the contact details provided below.
   • Advise the patient to contact their prescriber at their earliest opportunity if they have consumed incorrect 1mg strength tablet(s).
3. Please provide the prescribers of patients who have been dispensed Warfant 3mg Tablets since 02/02/2026 with a copy of the attached Dear Doctor Letter (in the Documents section at the bottom of this webpage).
4. If you have supplied any units of batch no. 25002 of Warfant 3mg Tablets to another pharmacy or facility, please forward a copy of the Pharmacist/Healthcare Professional recall letter (in the Documents section at the bottom of this webpage) to them so that they can perform the requested actions.
5. Please contact your wholesaler to arrange uplift of the quarantined units.

Information for Patients and Public

If you have received units from batch no. 25002 of Warfant 3mg Tablets, your pharmacist has been requested to contact you to check the tablets in your possesion are the correct strength. 

The correct Warfant 3mg Tablets are blue in colour and are marked with ‘W3’ on one side. The Warfant 1 mg Tablets are brown in colour and are marked with the ‘W1’ on one side.

If you have any queries, please contact your pharmacy.

Information for Wholesalers

Wholesalers are requested to perform the following actions:

1. Immediately identify and quarantine any units of batch no. 25002 of Warfant 3mg Tablets which you have in your facility.
2. A separate recall letter is being issued to pharmacists requesting them to contact their wholesaler to arrange the uplift of stock quarantined at pharmacies. Please facilitate uplift requests and quarantine uplifted stock within your facility.
3. If you have supplied batch no. 25002 of Warfant 3mg Tablets to any other wholesaler(s), please forward a copy of the Wholesale recall letter (in the Documents section at the bottom of this webpage) to those wholesalers, requesting that they immediately quarantine any unsold quantities of these packs, and return them back to you.
4. Please contact your wholesaler to arrange uplift of the quarantined units.

Documents

Opens in new window Warfant 3mg Tablets-Pharmacy and HCP recall letter-17Aug2026-pdf PDF : 347KB | 17/08/2026 Opens in new window Warfant 3mg Tablets-Wholesale recall letter-17Aug2026-pdf PDF : 333KB | 17/08/2026 Opens in new window Warfant 3mg Tablets-Dear Doctor letter-17Aug2026-pdf PDF : 199KB | 17/08/2026