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Eldepryl 5 mg Tablets, PA1327/003/001, Recall, One Batch

Notice type: Recall

Date: 16/09/2024

 We wish to advise you that one batch of Eldepryl 5 mg Tablets, PA1327/003/001, is being recalled with immediate effect.

This recall is to pharmacy/veterinary clinic level.

The reason for the recall is an out of specification result for assay, obtained during stability testing of the batch.

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

Product name or type:
Eldepryl 5 mg Tablets, PA1327/003/001

Authorisation Number:
PA1327/003/001

Product Classification:
Human

Serial Or Batch Number And Expiry Date:
Batch number: 2166322
Expiry Date: 07.2026

Authorisation Holder:
Orion Pharma

Recall Classification:
Pharmacy/veterinary clinic level

Actions To Be Taken:
Information for pharmacists:
Pharmacists are requested to 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 recall letter to them, and request they quarantine and return any unused units to you.

Information for veterinary clinics:
Veterinary clinics are requested to take the following actions:
1. Immediately identify and quarantine any units of this batch which you have in your clinic.
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 veterinary surgeon, clinic or other such establishment, please forward a copy of the recall letter to them, and request they quarantine and return any unused units to you.

Information for patients:
If you have any queries, please contact your pharmacist.

Adverse reactions should be reported to Orion Pharma (ie.medicalinformation@orionpharma.com) and to the HPRA (medsafety@hpra.ie).
 


 

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