Class 4 Medicines Defect Information: Co-trimoxazole 80mg/400mg per 5ml adult suspension (Aspen Pharma Trading Limited)
Drug alert number: EL (24)A/32
Date issued: 25 July 2024
The Medicines and Health products Regulatory Agency (MHRA) has issued a class 4 medicines defect information notice for: Co-trimoxazole 80mg/400mg per 5ml adult suspension (Aspen Pharma Trading Limited)
Company name: Aspen Pharma Trading Limited
Product name: Co-trimoxazole 80mg/400mg per 5ml adult suspension, PL 39699/0038
SNOMED Code: 32280411000001100
Batch Number
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.
View full alert here.
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: Aspenmedinfo@professionalinformation.co.uk,
Tel: 0800 008 7392
The post MHRA Class 4 Medicines Defect Information: Co-trimoxazole 80mg/400mg per 5ml adult suspension (Aspen Pharma Trading Limited) appeared first on Community Pharmacy England.