Octostim 1,5 mg/ml - Nasalspray

Recall | Medicines | 13/07/2020

The marketing authorisation holder informed its customers by July 13, 2020 that "Octostim 1,5 mg/ml - Nasalspray" is being recalled because of low volumes of the nasal sprays. Those low volumes may be caused by evaporation from the bottles and show out-of-specification results in both the active substance desmopressin and the excipient benzylalkonium chloride.

Name of the medicinal product Octostim 1,5 mg/ml - Nasalspray
Marketing authorisation number(s) 1-22010
CIP code 1313669
Marketing authorisation holder Ferring Arzneimittel Ges.m.b.H.
Batch number(s) Batch number / Expiry date
N15378A / 20.09.2020
P13756C / 31.08.2021
R13651C / 30.06.2022
R13651R / 30.06.2022
Classification of the recall2
Depth of recall Pharmacies
BASG reference number INS-640.001-3255

Further inquiry note