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The HPRA have advised 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.
You are requested to take the following actions:
1. 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. 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 12 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.
Should you have any queries, please contact Accord Healthcare Ireland Ltd. at number +353 21 4619040 or email qa_ireland@accord-healthcare.com.
Pharmacists can download a copy of the recall letter here.
