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: Aspenmedinfo@professionalinformation.co.uk,
Tel: 0800 008 7392
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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