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.

 

The post MHRA Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg Hard Capsules (Accord Healthcare Ltd) appeared first on Community Pharmacy England.