Atomoxetine Accord 10/18/25/40/60/80/100 mg Hard Capsules – PA2315/019/001-007
09/07/2024
Medicines for human use
Recall
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 in the documents attached to this notice.
Pharmacists can download a copy of the pharmacy recall letter in the documents attached to this notice.
Product information
- Authorisation holder
- Accord Healthcare Ireland Ltd
- Authorisation number
-
PA2315/019/001PA2315/019/002PA2315/019/003PA2315/019/004PA2315/019/005PA2315/019/006PA2315/019/007
- Serial or batch number and expiry date
- All in-date batches
- Human or veterinary medicine
- Human
- Target audience
- Pharmacists and Wholesalers
- Recall level
- Pharmacy level
Actions to be taken
Information for pharmacists:
Pharmacists are requested to carry out the following actions:
- 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.
- 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 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).