29th July 2024
Dear Customer,
Aspen Pharma Trading Limited has issued a Class 4 Medicines Defect Information – Caution in Use. In relation to:
Co-trimoxazole 80mg/400mg per 5ml adult suspension, PL 39699/0038
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.
The following details how the affected batches purchased through NVS were sold as.
|
NVS Product Code(s) |
Product Description | Affected Batch Number(s) | Expiry Date |
| 563390 | CO-TRIMOXAZOLE SUSP 80/400MG, 100ML | B18324E | 31st May 2028 |
| B99324E | 31st May 2028 | ||
| B05924E | 31st May 2028 | ||
| B98724E | 31st May 2028 | ||
| B95224A | 31st January 2028 | ||
| B95324A | 31st January 2028 | ||
| B22823GA | 31st July 2027 | ||
| B85623F | 30th June 2027 | ||
| B01923C | 31st March 2027 | ||
| B55023B | 28th February 2027 | ||
| B55323B | 28th February 2027 | ||
| B97222L | 31st December 2026 | ||
| B27922I | 30th September 2026 | ||
| B60922G | 31st July 2026 | ||
| B02122E | 31st May 2026 | ||
| B71922D | 30th April 2026 | ||
| B40821K | 30th November 2025 | ||
| B82321F | 30th June 2025 | ||
| B77321F | 30th June 2025 | ||
| B21921D | 30th April 2025 | ||
| B96420I | 30th September 2024 | ||
| B71220H | 31st August 2024 |
Advice for healthcare professionals
Please continue to use the product as normal but be aware of the typographical error highlighted above.
What to do next – Please read the attached notification letter (Please click here) and bring the issue to the attention of all relevant colleagues within your business.
