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

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

SNOMED Code

32280411000001100

Batch No Expiry Date Pack Size First Distributed
B18324E 31st May 2028 100ml July 2024
B99324E 31st May 2028 100ml July 2024
B05924E 31st May 2028 100ml July 2024
B98724E 31st May 2028 100ml July 2024
B95224A 31st January 2028 100ml April 2024
B95324A 31st January 2028 100ml April 2024
B22823GA 31st July 2027 100ml September 2023
B85623F 30th June 2027 100ml July 2023
B01923C 31st March 2027 100ml May 2023
B55023B 28th February 2027 100ml March 2023
B55323B 28th February 2027 100ml March 2023
B97222L 31st December 2026 100ml January 2023
B27922I 30th September 2026 100ml November 2022
B60922G 31st July 2026 100ml August 2022
B02122E 31st May 2026 100ml June 2022
B71922D 30th April 2026 100ml May 2022
B40821K 30th November 2025 100ml February 2022
B82321F 30th June 2025 100ml July 2021
B77321F 30th June 2025 100ml July 2021
B21921D 30th April 2025 100ml May 2021
B96420I 30th September 2024 100ml November 2020
B71220H 31st August 2024 100ml September 2020

Active Pharmaceutical Ingredient: sulfamethoxazole, trimethoprim

Brief description of the 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 for healthcare professionals

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

Advice for 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.

Further Information

For medical information enquiries please contact: [email protected],
Tel: 0800 008 7392

Yours faithfully

Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU

Telephone +44 (0)20 3080 6574

[email protected]

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

Updates to this page

Published 25 July 2024