Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 10mg, 40mg, 60mg, 80mg & 100mg Hard Capsules, EL(24)A/33

Source@ MHRA/Gov.uk 30.7.24

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 medical_information@glenmarkpharma.com

For stock control enquiries please email orders.uk@glenmarkpharma.com

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

DMRC@mhra.gov.uk

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Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Ltd, Atomoxetine 10mg, 18mg, 25mg, 10mg, 40mg, 60mg, 80mg & 100mg Hard Capsules, EL(24)A/33

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