Recall of a number of batches of Fluzac 20mg Capsules, PA711/110/1

Notice type: Recall

Date: 01/03/2024

We wish to advise you that the below listed batches of Fluzac 20mg Capsules, PA0711/110/001, are being recalled as a precautionary measure.

This recall is going to pharmacy level.

The precautionary recall is due to the presence of the nitrosamine impurity, N-nitroso-fluoxetine which was detected at levels above the acceptable regulatory limit in the below listed batches.

1. Check your current inventory and immediately quarantine any units of the above listed batches within your pharmacy. For hospital pharmacies, this includes stock on wards, in clinics and any at other relevant locations within your hospital.
2. If you have supplied units from the above listed batches to any other pharmacy, clinic or other such establishment, forward a copy of this recall letter to them, and request they quarantine and return any unused units to you.
3. Return all quarantined units to your wholesaler within the next two weeks.

Unaffected stock of Fluzac 20mg Capsules is available to order.