Class 2 Medicines recall: Efudix 5% w/w cream (Uni Health Distribution)

Drug alert number: EL (22) A/07

Date issued: 17th February 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a class 2 medicines recall for:

Efudix 5% w/w cream (Uni Health Distribution) PL 45396/0088

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.

Full drug alert can be viewed here.

Company contacts for 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