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

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

Accord Healthcare Ltd is recalling various 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 113-05/24

Company name: Accord Healthcare Ltd

Product description: Atomoxetine 10mg Hard Capsules, PL 20075/1173

SNOMED Code: 37277411000001106

Details of the affected batch: 

Product description: Atomoxetine 18mg Hard Capsules, PL 20075/1174

SNOMED Code: 37276511000001108

Product description: Atomoxetine 25mg Hard Capsules, PL 20075/1175

SNOMED Code: 37276811000001106

Product description: Atomoxetine 40mg Hard Capsules, PL 20075/1176

SNOMED Code: 37277111000001101

Product description: Atomoxetine 60mg Hard Capsules PL 20075/1177

SNOMED Code: 37276311000001102

Product description: Atomoxetine 80mg Hard Capsules, PL 20075/1178

SNOMED Code: 37275711000001106

Product description: Atomoxetine 100mg Hard Capsules, PL 20075/1179

SNOMED Code: 37276111000001104

Active Pharmaceutical Ingredient: atomoxetine hydrochloride

Brief description of 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 to 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 to 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.

Company contacts for 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.

To access the full recall: 

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