Octostim 1,5 mg/ml - Nasalspray
Recall
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Medicines
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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 recall | 2 |
| Depth of recall | Pharmacies |
| BASG reference number | INS-640.001-3255 |
Further inquiry note
Page last modified:
13/07/2020