Ergovasan
Recall
|
Medicines
|
20/03/2014
The marketing authorization holder informed its supplied customers in a letter dated 19.03.2014 that underfilling of the15 ml package size had been detected. This is not a case of underfilling during production, but of evaporation of the alcohol due to drip fittings not fitting tightly. This evaporation subsequently leads to a concentration of the active ingredient of up to 85%.
| Name of the medicinal product | Ergovasan 2 mg/ml -Tropfen |
|---|---|
| Marketing authorisation number(s) | 1-19270 |
| Marketing authorisation holder | WABOSAN Arzneimittelvertriebs GmbH |
| Batch number(s) | 08 |
| Expiry date | 09/03/2019 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 1048 |
Further inquiry note
Page last modified:
12/07/2022