Spironolactone 100mg film-coated tablets – PA2315/119/003 – One batch
09/08/2024
Medicines for human use
Recall
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 in the documents attached to this notice.
Wholesalers can download a copy of the wholesaler recall letter in the documents attached to this notice.
Product information
- Authorisation holder
- Accord Healthcare Ireland Ltd.
- Authorisation number
- PA2315/119/003
- Serial or batch number and expiry date
-
Batch number: D2400486Expiry date: 01/2027
- Human or veterinary medicine
- Human
- Target audience
- Pharmacists and Wholesalers
- Recall level
- Pharmacy level recall
Actions to be taken
Information for pharmacists:
Pharmacists are requested to please take the following actions:
- 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.
- Return quarantined units to your supplier, indicating that they are being returned as a result of this recall action.
- 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:
- Immediately identify and quarantine any units of this batch in your possession, or that are returned to you.
- 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.
- 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).