Class 3 Medicines Recall: Neuraxpharm UK Ltd, Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules, EL(24)A/19
Neuraxpharm UK Ltd is recalling specific 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 078-05/24
Company name
Neuraxpharm UK Ltd
Product name
Atomoxetine 10mg Capsules, PL 49718/0010
SNOMED Code
37858111000001106
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1211145 | 09/2025 | 7 | 23/02/2023 |
| 1203816 | 03/2025 | 7 | 07/07/2022 |
Product name
Atomoxetine 18mg Capsules, PL 49718/0011
SNOMED Code
37858311000001108
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1211146 | 09/2025 | 7 | 23/02/2023 |
Product name
Atomoxetine 25mg Capsules, PL 49718/0012
SNOMED Code
37858511000001102
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1211147 | 06/2025 | 7 | 23/02/2023 |
| 1207940 | 06/2025 | 7 | 24/10/2022 |
Product name
Atomoxetine 40mg Capsules, PL 49718/0013
SNOMED Code
37900111000001107
| Batch Number | Expiry Date | Pack Size | First Distributed |
|---|---|---|---|
| 1211148 | 09/2025 | 7 | 23/02/2023 |
| 1203818 | 03/2025 | 7 | 07/07/2022 |
Active Pharmaceutical Ingredient: Atomoxetine
Brief description of the problem
Neuraxpharm UK 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 medinfo-uk@neuraxpharm.com or telephone +44 (0) 118 211 4039
For stock control enquiries please contact info-uk@neuraxpharm.com or telephone +44 (0) 118 211 4039
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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