Atomoxetine Capsules USP 80mg, Exempt Medicinal Product (Glenmark Pharmaceuticals Inc. livery)
14/02/2025
Medicines for human use
Recall
We wish to advise you that the below listed batches of Atomoxetine Capsules USP 80mg are being recalled with immediate effect. These batches have been supplied to you as an Exempt Medicinal Product (EMP) by Uniphar.
The recall is going to pharmacy level.
The recall letter, dated 11/02/2025, can be downloaded in the Documents section at the bottom of this webpage.
The recall is due to the presence of a nitrosamine impurity, N-Nitroso Atomoxetine at levels which exceed the current acceptable intake.
Product information
- Active substance
- Atomoxetine
- Authorisation holder
- Glenmark
- Manufacturer or supplier
- Uniphar
- Serial or batch number and expiry date
- see table below
- Human or veterinary medicine
- Human
- Target audience
- Pharmacists
- Recall level
- Pharmacy level recall
Actions to be taken
Information for Pharmacists
Pharmacists are requested to:
- Check your current inventory and immediately quarantine any units of the batches which you have in 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 the batches to any other pharmacy or any other healthcare facility, please contact them and request that they return any unused units to you.
- Return quarantined stock to Uniphar by 25-Feb-2025.
Replacement stock is not available to order.
Should you have any queries, please contact Eileen Carroll at psguality@uniphar.ie and telephone number: +353 (0)1-4687660.
Information for Patients and Public
If you have this medication in your possession and have any queries, please contact your pharmacist.
Suspected adverse reactions should be reported to psguality@uniphar.ie and the Health Products Regulatory Authority (medsafety@hpra.ie).
Reference
| Batch number | Expiry |
| 19234153 | 2025/09/30 |
| 19234929 | 2025/11/30 |