MHRA Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)

Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)

Drug alert number: EL (24)A/25

Date issued: 02 July 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd)

Company name: Accord Healthcare Ltd

Product name: Atomoxetine 10mg Hard Capsules, PL 20075/1173

SNOMED Code: 337277411000001106

Batch Number 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 Number 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 Capsules, PL 49718/0012

SNOMED Code: 37276811000001106

Batch Number 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 Apr 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 Number 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 Number 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 Number 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 13 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 Number 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

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.

View full alert here.

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.

 

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