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

Drug alert number: EL (24)A/33

MDR number: MDR 113-05/24

Date issued: 30 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 (Glenmark Pharmaceuticals Europe Ltd)

Company name: Glenmark Pharmaceuticals Europe Ltd

Product name: Atomoxetine 10mg Hard Capsules, PL 25258/0270

SNOMED Code: 337277411000001106

Batch Number
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

Product name: Atomoxetine 18mg Hard Capsules, PL 25258/0271

SNOMED Code: 37535211000001107

Batch Number
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

Product name: Atomoxetine 25mg Capsules, PL 25258/0272

SNOMED Code: 37531811000001105

Batch Number
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

Product name: Atomoxetine 40mg Hard Capsules, PL 25258/0273

SNOMED Code: 37535411000001106

Batch Number
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

Product name: Atomoxetine 60mg Hard Capsules, PL 25258/0274

SNOMED Code: 37532411000001103

Batch Number
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

Product name: Atomoxetine 80mg Hard Capsules, PL 25258/0275

SNOMED Code: 37533211000001108

Batch Number
Expiry date
Pack size
First distributed

1205406
31-Mar-2025
28
26-Jul-2022

1309733
30-Sep-2026
28
30-Nov-2023

Product name: Atomoxetine 100mg Hard Capsules, PL 25258/0276

SNOMED Code: 37533711000001101

Batch Number
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.

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 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

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