Recall due to exceeding the specification for related substances

Recall due to colourless, instead of milky white emulsion

Recall due to increased reports of ring breakage

Recall due to particles affecting batches 8234, 8235 und 8236

Recall due to reduced active ingredient content

Recall due to suspension of the marketing authorization

Marketing authorisation holders of homeopathic human medicinal products are informed that from 01.01.2020 [i.e. from the Data Lock Point: 30.09.2019] no further PSUR submissions are necessary, unless they are ordered by the BASG on a case-by-case basis.

The manufacturer informed its customers on 04 December, 2019, that the stated value of the active pharmaceutical ingredient content was too high.

The manufacturer informed its customers on 03 December, 2019, that the listed batches of active pharmaceutical ingredients are recalled as a precautionary measure due to the withdrawal of the manufacturer's certificate of the Indian original manufacturer "Mehta API Pvt. Ltd.".

Die Zulassungsinhaberin hat die belieferten Kundinnen und Kunden mit Schreiben vom 20.11.2019 informiert, dass aufgrund von eingeleiteten Untersuchungen auf europäischer Ebene eine Verunreinigung des Wirkstoffes Ranitidin mit N-Nitrosodimethylamin (NDMA) bei oben angeführten Zulassungen von Ulsal nicht ausgeschlossen werden kann.