MHRA Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules (Neuraxpharm UK Ltd)

Class 3 Medicines Recall: Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules (Neuraxpharm UK Ltd)

Drug alert number: EL (24)A/19

Date issued: 5 June 2024

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for: Atomoxetine 10mg, 18mg, 25mg, 40mg Capsules (Neuraxpharm UK Ltd)

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.

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 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

 

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