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
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 |
Active Pharmaceutical Ingredient: Atomoxetine Hydrochloride
Brief description of the 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 for 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 for 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.
Further Information
For medical information enquiries please use the following options by phone +44 08004 580 383 or email [email protected]
For stock control enquiries please email [email protected]
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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