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Recall of one batch of Duloxetine Accord 30 mg hard gastro-resistant capsules and one batch of Duloxetine Accord 60 mg hard gastro-resistant capsules

Notice type: Recall

Date: 02/04/2024

 We wish to advise you that batch no. 230804 of Duloxetine Accord 30 mg hard gastro-resistant capsules (PA2315/268/001) and batch no. 230797 of Duloxetine Accord 60 mg hard gastro-resistant capsules (PA2315/268/002) are being recalled with immediate effect.

The recall is going to pharmacy level. The reason for the recall is due to the detection of N-nitroso-duloxetine.

Pharmacists can download a copy of the recall letter here.

Product name or type:
Duloxetine Accord 30 mg hard gastro-resistant capsules and Duloxetine Accord 60 mg hard gastro-resistant capsules

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

Authorisation Holder:
Accord Healthcare Ireland Ltd.

Recall Classification:
Pharmacy level recall

Target Audience:
Pharmacists

Actions To Be Taken:
Pharmacists are requested to take the following actions:
1. 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.
2. 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.
3. 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.

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