Company led medicines recall: Dermaved Sensitive Cream (unlicensed medicine), CLMR (21)A/09

Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w).

MDR Number: MDR 251-12/21

Company name: Dermaved

Product description: Dermaved Sensitive Cream (unlicensed medicine)

Details of the affected batch:

Brief description of problem:

Dermaved is recalling the above product from patients due to presence of clobetasol propionate (0.001% w/w). This product is supplied by Dermaved online.

The company’s investigation is on-going. Remaining stock of the above product should be returned to the company directly.

Clobetasol propionate is a strong steroid and it is an active ingredient in Prescription Only Medicines used for the treatment skin conditions such as psoriasis and eczema. Creams containing steroids should be used sparingly and as directed by the prescriber.

Although the presence of clobetasol propionate in this product is low, patients are advised to stop using the cream immediately, particularly pregnant and breastfeeding women, babies and young children.

There have been infrequent cases of skin reactions after stopping the use of creams containing steroids. Patients are advised to consult a doctor if their skin worsens within 2 weeks of stopping this cream or if they experience any side-effects from using this product. Suspected side effects should also be reported via the Yellow Card Scheme.

Company contacts for further information:

For more information, please contact Dermaved: info@dermaved.com.