Class 4 Medicines Defect Information: Aspen Pharma Trading Limited

Class 4 Medicines Defect Information: Aspen Pharma Trading Limited, Co-trimoxazole 80mg/400mg per 5ml adult suspension, EL (24)A/32

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

MDR Number: MDR 063-03/24

Company name: Aspen Pharma Trading Limited

Product description: Co-trimoxazole 80mg/400mg per 5ml adult suspension, PL 39699/0038

SNOMED Code: 32280411000001100

Details of the affected batch: 

Active Pharmaceutical Ingredient: sulfamethoxazole, trimethoprim

Brief description of problem:

Aspen Pharma Trading Limited has informed the MHRA that an error has been found in the Patient Information Leaflet.

The error is in the section, ‘What co-trimoxazole looks like and contents of the pack’. The PIL states ‘4001mg sulfamethoxazole’ instead of ‘400 mg sulfamethoxazole’. The other sections of the PIL and product information state the correct strength.

Advice to Healthcare Professionals:

Please continue to use the product as normal but be aware of the typographical error highlighted above.

Advice to Patients:

No further action is required by patients. Patients should continue to receive this medicine from these batches as given to you by your healthcare professional. There is no impact to product quality. If you have concerns about a medicine you may be using, please contact 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: Aspenmedinfo@professionalinformation.co.uk,

Tel: 0800 008 7392

To access the full recall: 

Class 4 Medicines Defect Information: Aspen Pharma Trading Limited, Co-trimoxazole 80mg/400mg per 5ml adult suspension, EL(24)A/32