Recall due to possible lack of efficacy and unintentional ingestion in non-target species

After a review process lasting almost a year, the WHO decided on 14.05.2024 to include the European network of EU and EEA medicines authorities, of which the Federal Office for Safety in Health Care is an essential and active part, as a recognized "regional entity" in the list of WHO Listed Authorities (WLA) for human medicines and vaccines.

"Extreme White Lightening Cream" contained the declared glucocorticoid clobetasol propionate and is therefore to be classified as an illegal medicinal product.

Recall due unknown impurity

Up-to-date information from the 22.04.-25.04.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

The Federal Office for Safety in Health Care was informed by the Danish authority that it had been informed by the Danish tissue bank European Sperm Bank (DK257572) that a "non-classical adrenogenital syndrome" had been reported in an offspring of the sperm donor 8845 BERRY.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that one offspring of donor 25639-TESSER has been diagnosed with 22q11 duplication syndrome.

Precautionary batch recall as a glass splinter was discovered in a 60 ml bottle.

Recall due to possible contamination with glass splinters

Up-to-date information from the 27.03.-30.03.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.