Class 3 Medicines Recall: Accord Healthcare Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules, EL(24)A/25
Accord Healthcare Ltd is recalling various 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.
MDR number
MDR 113-05/24
Company name
Accord Healthcare Ltd
Product name
Atomoxetine 10mg Hard Capsules, PL 20075/1173
SNOMED Code
37277411000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1110078 | Jul 2024 | 28 | 08 Nov 2021 |
| 1111874 | Aug 2024 | 28 | 15 Dec 2021 |
| 1200540 | Oct 2024 | 28 | 15 Mar 2022 |
| 1203856 | Mar 2025 | 28 | 21 Jun 2022 |
| 1207106 | Jun 2025 | 28 | 24 Oct 2022 |
| 1300367 | Sep 2024 | 28 | 01 Mar 2023 |
| 1300368 | Oct 2025 | 28 | 02 May 2023 |
| 1308974 | Jul 2026 | 28 | 19 Jan 2024 |
| 1308975 | Aug 2026 | 28 | 19 Feb 2024 |
| 1111687 | Aug 2024 | 7 | 30 Dec 2021 |
| 1203285 | Mar 2025 | 7 | 20 Jun 2022 |
| 1207790 | Jun 2025 | 7 | 07 Nov 2022 |
| 1210683 | Sep 2025 | 7 | 16 Jan 2023 |
| 1304125 | Apr 2026 | 7 | 13 Jul 2023 |
| 1307898 | Jul 2026 | 7 | 08 Nov 2023 |
Product name
Atomoxetine 18mg Hard Capsules, PL 20075/1174
SNOMED Code
37276511000001108
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1203283 | Mar 2025 | 28 | 16 Jun 2022 |
| 1203896 | Mar 2025 | 28 | 08 Sep 2022 |
| 1207494 | Jun 2025 | 28 | 31 Oct 2022 |
| 1208784 | Jun 2025 | 28 | 17 Jan 2023 |
| 1208785 | Jul 2025 | 28 | 28 Mar 2023 |
| 1307499 | Jun 2026 | 28 | 15 Dec 2023 |
| 1309668 | Sep 2026 | 28 | 07 Mar 2024 |
| 1111061 | Jul 2024 | 7 | 20 Dec 2021 |
| 1200640 | Aug 2024 | 7 | 21 Jun 2022 |
| 1300503 | Oct 2025 | 7 | 02 Mar 2023 |
| 1307890 | Jul 2026 | 7 | 08 Mar 2024 |
Product name
Atomoxetine 25mg Hard Capsules, PL 20075/1175
SNOMED Code
37276811000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1110084 | Aug 2024 | 28 | 19 Nov 2021 |
| 1111119 | Aug 2024 | 28 | 11 Jan 2022 |
| 1200055 | Oct 2024 | 28 | 11 Feb 2022 |
| 1208724 | Jun 2025 | 28 | 23 Jan 2023 |
| 1309624 | Aug 2026 | 28 | 29 Jan 2024 |
| 1309625 | Sep 2026 | 28 | 28 Mar 2024 |
| 1309685 | Sep 2026 | 28 | 08 Mar 2024 |
| 1111692 | Aug 2024 | 7 | 14 Dec 2021 |
| 1200641 | Oct 2024 | 7 | 04 Ap 2022 |
| 1207151 | May 2025 | 7 | 23 Dec 2022 |
| 1306982 | Jun 2026 | 7 | 05 Apr 2024 |
| 1307214 | Jun 2026 | 7 | 29 Jan 2024 |
Product name
Atomoxetine 40mg Hard Capsules, PL 20075/1176
SNOMED Code
37277111000001101
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1110101 | Aug 2024 | 28 | 17 Nov 2021 |
| 1111708 | Oct 2024 | 28 | 25 Jan 2022 |
| 1203171 | Mar 2025 | 28 | 15 Jun 2022 |
| 1204488 | Mar 2025 | 28 | 25 Jul 2022 |
| 1205675 | Apr 2025 | 28 | 01 Sep 2022 |
| 1207018 | Jun 2025 | 28 | 20 Sep 2022 |
| 1307133 | Jun 2026 | 28 | 13 Sep 2023 |
| 1309726 | Sep 2026 | 28 | 08 Feb 2024 |
| 1200643 | Dec 2024 | 7 | 30 May 2022 |
| 1207152 | Jun 2025 | 7 | 03 Oct 2022 |
| 1300507 | Nov 2025 | 7 | 06 Mar 2023 |
| 1307251 | Jun 2026 | 7 | 22 Mar 2024 |
Product name
Atomoxetine 60mg Hard Capsules PL 20075/1177
SNOMED Code
37276311000001102
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1111748 | Aug 2024 | 28 | 10 Dec 2021 |
| 1200173 | Aug 2024 | 28 | 07 Mar 2022 |
| 1200600 | Oct 2024 | 28 | 17 Oct 2022 |
| 1200601 | Oct 2024 | 28 | 19 Apr 2022 |
| 1206867 | Jun 2025 | 28 | 16 Jan 2023 |
| 1300717 | Dec 2025 | 28 | 31 Mar 2023 |
| 1308067 | Jul 2026 | 28 | 23 Oct 2023 |
| 1401176 | Nov 2026 | 28 | 13 Mar 2024 |
Product name
Atomoxetine 80mg Hard Capsules, PL 20075/1178
SNOMED Code
37275711000001106
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1111226 | Aug 2024 | 28 | 13 Dec 2021 |
| 1203290 | Feb 2025 | 28 | 16 Jun 2022 |
| 1206825 | May 2025 | 28 | 03 Oct 2022 |
| 1208609 | Jun 2025 | 28 | 30 Dec 2022 |
| 1301062 | Sep 2025 | 28 | 09 Mar 2023 |
| 1301063 | Nov 2025 | 28 | 17 Jul 2023 |
| 1307545 | Jul 2026 | 28 | 06 Nov 2023 |
| 1309767 | Sep 2026 | 28 | 19 Mar 2024 |
| 1309768 | Sep 2026 | 28 | 09 Feb 2024 |
Product name
Atomoxetine 100mg Hard Capsules, PL 20075/1179
SNOMED Code
37276111000001104
| Batch No | Expiry Date | Pack Size | First Distributed |
| 1111229 | Aug 2024 | 28 | 13 Jan 2022 |
| 1206820 | May 2025 | 28 | 29 Sep 2022 |
| 1209117 | May 2025 | 28 | 30 Dec 2022 |
| 1210645 | Jun 2025 | 28 | 09 Oct 2023 |
| 1302718 | Jan 2026 | 28 | 08 Mar 2024 |
| 1302719 | Jun 2025 | 28 | 12 Jun 2023 |
Active Pharmaceutical Ingredient: atomoxetine hydrochloride
Brief description of the problem
Accord Healthcare 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 batches 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 contact Accord-UK Ltd Medical Information Department on 01271 385257
For stock control enquiries please contact Accord- UK Ltd Customer Services Team on 0800 373573.
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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