Alustal, Phostal, Staloral
Recall
|
Medicines
|
17/12/2015
The marketing authorization holder and its distribution partner informed the supplied customers in a letter dated 14.12.2015 that after the introduction of a new IT system in the production facility "Stallergenes S.A." in Antony, France, difficulties were identified which resulted in operational malfunctions as well as in some incorrect deliveries. By order of the French health authority (ANSM), production in Antony, France, was temporarily stopped as of December 02, 2015, and a recall of the above-mentioned products for patient-specific treatment was initiated.
| Name of the medicinal product | 1. Alustal Suspension zur Injektion 2. Phostal Suspension zur Injektion 3. Staloral Sublinguale Lösung |
|---|---|
| Marketing authorisation number(s) | 1. ALL - 0013 2. ALL - 0014 3. ALL - 0012 |
| Marketing authorisation holder | Stallergenes S.A. Vertrieb und Durchführung Rückruf: Kwizda Pharmadistribution GmbH |
| Batch number(s) | Alle Auslieferungen seit 13.08.2015 |
| Classification of the recall | 1 |
Further inquiry note
Page last modified:
12/07/2022