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Spironolactone 100mg film-coated tablets, PA2315/119/003, Recall, One Batch

Notice type: Recall

Date: 09/08/2024

 We wish to advise you that one batch of Spironolactone 100mg film-coated tablets, PA2315/119/003, is being recalled with immediate effect.

This recall is to pharmacy level.

The reason for the recall is due to visible contamination on a small number of tablets within this batch.

Pharmacists can download a copy of the pharmacy recall letter. 
Wholesalers can download a copy of the wholesaler recall letter. 

Product name or type:
Spironolactone 100mg film-coated tablets

Authorisation Number:
PA2315/119/003

Serial Or Batch Number And Expiry Date:
Batch number: D2400486
Expiry date: 01/2027

Authorisation Holder:
Accord Healthcare Ireland Ltd.

Recall Classification:
Pharmacy level recall

Target Audience:
Pharmacists and Wholesalers

Actions To Be Taken:
Information for pharmacists:

Pharmacists are requested to please take the following actions:
1. Immediately identify and quarantine any units of this batch which you have in your pharmacy. For hospital pharmacists, this includes stock on wards, in clinics and at any other relevant locations within your hospital.
2. Return quarantined units to your supplier, indicating that they are being returned as a result of this recall action. 
3. If you have supplied units of this batch to any other pharmacy, clinic or other such establishment, please forward a copy of the pharmacy recall letter to them, and request they quarantine and return any unused units to you.

Information for wholesalers:

Wholesalers are requested to please take the following actions:
1. Immediately identify and quarantine any units of this batch in your possession, or that are returned to you.
2. Identify whether you have supplied any units of this batch to any other wholesaler. If you have done so, please forward a copy of the wholesaler recall letter to those wholesalers, requesting that they immediately quarantine and return any unsold units to you.
3. Return quarantined stock to Allphar Services Ltd., indicating that the stock is being returned as a result of this recall action.

Information for patients:

If you have any queries, please contact your pharmacist.

Adverse reactions should be reported to Accord (medinfo@accord-healthcare.com) and to the HPRA (medsafety@hpra.ie).

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