Duloxetine Accord 30 mg and 60 mg hard gastro-resistant capsules – One batch each
02/04/2024
Medicines for human use
Recall
We wish to advise you that one batch of Duloxetine Accord 30 mg hard gastro-resistant capsules and one batch of Duloxetine Accord 60 mg hard gastro-resistant capsules is being recalled with immediate effect.
The recall is going to pharmacy level.
Problem or issue
The reason for the recall is due to the detection of N-nitroso-duloxetine.
A copy of the recall letter is provided in the Documents section below.
Product information
- Authorisation holder
- Accord Healthcare Ireland Ltd.
- Authorisation number
-
PA2315/268/001and PA2315/268/002
- Serial or batch number and expiry date
-
Batch no. 230804, expiry 03/2026 and batch no. 230797, expiry 02/2026
- Human or veterinary medicine
- Human medicine
- Target audience
- Pharmacists
- Recall level
- Pharmacy level
Actions to be taken
Information for pharmacists
Pharmacists are requested to take the following actions:
- Please immediately quarantine any units of the batches which you have in your pharmacy. For hospital pharmacists, this request includes stock on wards, in clinics and at any other relevant locations within your hospital.
- Please return quarantined units to your supplier, indicating that they are being returned as a result of this recall action. The final date for recalled stock to be received back for credit is 12th April 2024.
- If you have supplied units from these batches to any other pharmacy, clinic or other such establishment, please forward a copy of this recall letter to them, and request they quarantine and return any unused units to you.
Replacement stock is currently unavailable.
Information for patients
No action is required at patient level; however, if you have any concerns, please contact your pharmacist.