Atomoxetine Capsules USP 25mg and Atomoxetine Capsules USP 40mg, Exempt Medicinal Products (Glenmark Pharmaceuticals Inc. livery)
06/02/2025
Medicines for human use
Recall
We wish to advise you that the below listed batches of Atomoxetine Capsules USP are being recalled with immediate effect. These batches have been supplied to you as an Exempt Medicinal Product (EMP) by Medisource or United Drug.
The recall letter can be downloaded in the Documents section at the bottom of this webpage.
The recall is going to pharmacy level.
The recall is due to the presence of a nitrosamine impurity, N-Nitroso Atomoxetine at levels which exceed the current acceptable intake.
Product information
- Manufacturer or supplier
- Medisource or United Drug
- Serial or batch number and expiry date
-
See table below.
- Human or veterinary medicine
- Human
- Target audience
- Pharmacists
- Recall level
- Pharmacy level
Actions to be taken
Information for Pharmacists
Pharmacists are requested to:
- Check your current inventory and immediately quarantine any units of the above batches within your pharmacy. For hospital pharmacies, this includes units at wards, clinics and any other relevant locations within the hospital.
- If you have supplied units from these batches to any other pharmacy, clinic or other such establishment, forward a copy of the recall letter to them, and request they quarantine and return any unused units to you.
- Contact your supplier to arrange the return of quarantined stock.
Alternative replacement stock is currently available to order.
Should you have any queries, please contact Ríona Howard on telephone number 01-2866366 or email Riona.Howard@medisource.ie.
Information for Patients
If you have this medication in your possession and have any queries, please contact your pharmacist.
Adverse events should be reported to regulatory@medisource.ie and to the HPRA (medsafety@hpra.ie).
Reference
| Product name | Batch number | Expiry |
| Atomoxetine Capsules, USP 25mg | 19233795 | 2025/08/31 |
| 19241477 | 2026/03/31 | |
| 19242599 | 2026/06/30 | |
| 19243162 | 2026/07/31 | |
| 19243163 | 2026/07/31 | |
| 19243884 | 2026/09/30 | |
| 19243887 | 2026/09/30 | |
| Atomoxetine Capsules, USP 40mg | 19234109 | 2025/09/30 |
| 19234897 | 2025/11/30 | |
| 19240501 | 2026/01/31 | |
| 19241806 | 2026/04/30 |