Eldepryl 5 mg tablets – PA1327/003/001 – One batch

16/09/2024

Medicines for human use Recall

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.

Copies of the recall letters are provided in the Documents section below.

Product information

Authorisation holder: Orion Pharma
Authorisation number: PA1327/003/001
Serial or batch number and expiry date: Batch number: 2166322
Expiry Date: 07.2026
Recall level: Pharmacy/veterinary clinic level

Pharmacists are requested to 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 recall letter to them, and request they quarantine and return any unused units to you.

Veterinary clinics are requested to take the following actions:

Immediately identify and quarantine any units of this batch which you have in your clinic.
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 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.

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).