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Atomoxetine Accord 10/18/25/40/60/80/100 mg - Hard Capsules, PA2315/019/001-007, Recall, All in-date batches

Notice type: Recall

Date: 09/07/2024

 We wish to advise you that all in-date batches of the above products are being recalled with immediate effect. 

This recall is to pharmacy level. 

The reason for the recall is out of specification assay results. 

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

Product name or type:
Atomoxetine Accord Hard Capsules

Authorisation Number:
PA2315/019/001, PA2315/019/002, PA2315/019/003, PA2315/019/004, PA2315/019/005, PA2315/019/006, PA2315/019/007

Serial Or Batch Number And Expiry Date:
All in-date batches

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 carry out the following actions:
1. Immediately identify and quarantine any units of these products 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 these products 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 patients:
If you have any queries, please contact your prescriber or pharmacist.

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

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