Class 2 Medicines Recall: Uni Health Distribution, Efudix 5% w/w cream, EL (22)A 07
Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect.
MDR number
233-01/22
Company name
Uni Health Distribution
Product description
Efudix 5% w/w cream PL 45396/0088
| Batch number | Expiry date | Pack size | First distributed |
|---|---|---|---|
| 80193439/B | 11/2025 | 2 x 20g | 28 October 2021 |
Active Pharmaceutical Ingredient: Fluorouracil
Brief description of the problem
Uni Health Distribution is aware of a potential issue where the leaflet contained within Efudix 5% w/w cream (2 x 20g) pack, batch 80193439/B may be incorrect. The issue was identified due to a market complaint which noted that ‘Trajenta 5mg tablets leaflet has been found in an Efudix 5% w/w cream.’ Uni Health Distribution have checked the packs within their possession and have not identified this issue in other packs, however the batch is being recalled from pharmacies as a precautionary measure.
Advice for healthcare professionals
Stop supplying the above batch immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.
Uni Health Distribution and impacted suppliers will be contacting the pharmacies directly who have been supplied the product. Healthcare professionals are urged to share an appropriate leaflet with the patient where possible. This product has been distributed in small volumes and based on the specific need for patients, this product is not being recalled from patients. The correct leaflet can be found here: Link to Efudix 5% w/w Cream PIL
Further Information
- For more information, please contact or email Margaret Fairney margaret@ennogen.com
- For medical information queries, please contact or email Margaret Fairney margaret@ennogen.com
- For supply queries, please contact Davide Rinaldi purchasing@ennogen.com
Recipients of this Medicines Recall should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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