Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Atomoxetine 10mg, 18mg, 25mg, 10mg, 40mg, 60mg, 80mg & 100mg Hard Capsules, EL(24)A/33
Glenmark Pharmaceuticals Europe Ltd is recalling various batches after retesting showed out of specification results.
MDR Number: MDR 113-05/24
Company name: Glenmark Pharmaceuticals Europe Ltd
Details of the affected batches:
Atomoxetine 10 mg Hard Capsules, PL 25258/0270 SNOMED Code 37277411000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1201584 | 31-Jan-2025 | 28 | 28-Apr-2022 |
| 1203056 | 31-Jan-2025 | 28 | 27-May-2022 |
| 1203859 | 31-Mar-2025 | 28 | 12-Jul-2022 |
| 1205342 | 31-May-2025 | 28 | 26-Jul-2022 |
| 1205816 | 31-May-2025 | 28 | 25-Aug-2022 |
| 1208831 | 31-May-2025 | 28 | 30-Nov-2022 |
| 1208832 | 31-Jul-2025 | 28 | 05-Dec-2022 |
| 1211181 | 31-Oct-2025 | 28 | 15-Feb-2023 |
| 1211187 | 31-Oct-2025 | 28 | 16-Mar-2023 |
| 1302767 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1302768 | 31-Dec-2025 | 28 | 24-May-2023 |
| 1307838 | 31-Jul-2026 | 28 | 12-Oct-2023 |
| 1307883 | 31-Jul-2026 | 28 | 17-Oct-2023 |
| 1307884 | 31-Jul-2026 | 28 | 17-Oct-2023 |
| 1310439 | 31-Oct-2026 | 28 | 03-Jan-2024 |
| 1311234 | 31-Oct-2026 | 28 | 19-Jan-2024 |
Atomoxetine 18 mg Hard Capsules, PL 25258/0271 SNOMED Code 37535211000001107
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1207734 | 30-Jun-2025 | 28 | 16-Nov-2022 |
| 1207741 | 31-Jul-2025 | 28 | 30-Nov-2022 |
| 1208833 | 31-Jul-2025 | 28 | 05-Dec-2022 |
| 1302771 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1307741 | 30-Jun-2026 | 28 | 17-Oct-2023 |
| 1400621 | 30-Nov-2026 | 28 | 28-Feb-2024 |
| 1400622 | 30-Nov-2026 | 28 | 13-Mar-2024 |
Atomoxetine 25 mg Hard Capsules, PL 25258/0272 SNOMED Code 37531811000001105
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1201599 | 30-Oct-2024 | 28 | 30-Mar-2022 |
| 1203920 | 31-Mar-2025 | 28 | 08-Jul-2022 |
| 1208834 | 31-Aug-2025 | 28 | 25-Nov-2022 |
| 1211263 | 31-Aug-2025 | 28 | 15-Feb-2023 |
| 1302773 | 28-Feb-2026 | 28 | 24-May-2023 |
| 1308796 | 31-Aug-2026 | 28 | 17-Nov-2023 |
Atomoxetine 40 mg Hard Capsules, PL 25258/0273 SNOMED Code 37535411000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1201647 | 31-Dec-2024 | 28 | 09-May-2022 |
| 1205403 | 31-May-2025 | 28 | 26-Jul-2022 |
| 1211316 | 30-Sep-2025 | 28 | 16-Feb-2023 |
Atomoxetine 60 mg Hard Capsules, PL 25258/0274 SNOMED Code 37532411000001103
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1208837 | 31-Aug-2025 | 28 | 05-Dec-2022 |
| 1211733 | 30-Nov-2025 | 28 | 15-Feb-2023 |
| 1308188 | 31-Jul-2026 | 28 | 30-Oct-2023 |
Atomoxetine 80 mg Hard Capsules, PL 25258/0275 SNOMED Code 37533211000001108
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1205406 | 31-Mar-2025 | 28 | 26-Jul-2022 |
| 1309733 | 30-Sep-2026 | 28 | 30-Nov-2023 |
Atomoxetine 100 mg Hard Capsules, PL 25258/0276 SNOMED Code 37533711000001101
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1211509 | 31-Oct-2025 | 28 | 28-Feb-2023 |
| 1309825 | 30-Sep-2026 | 28 | 18-Dec-2023 |
Brief description of problem:
Glenmark Pharmaceuticals Europe Ltd is recalling the above batches after retesting showed out of specification results. The tabled batches are being recalled as a precautionary measure after testing showed variability of the capsule contents beyond permitted levels.
Advice to Healthcare Professionals:
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Advice to Patients:
No further action is required by patients as this recall is being undertaken at a Pharmacy and Wholesaler level as a precautionary measure. Patients should continue to take medicines from these batches as prescribed by your healthcare professional.
Patients who experience adverse reactions or have any questions about the medication, should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Company contacts for further information:
For medical information enquiries please use the following options by phone +44 08004 580 383 or email medical_information@glenmarkpharma.com
For stock control enquiries please email orders.uk@glenmarkpharma.com
To access the full recall: Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Atomoxetine 10mg, 18mg, 25mg, 10mg, 40mg, 60mg, 80mg & 100mg Hard Capsules, EL(24)A/33