Ferring Statement on Minirin®/Octostim®/DDAVP®/Stimate® (desmopressin) Nasal Spray
Saint-Prex, Switzerland – 9 February, 2021 – Minirin® (desmopressin) Nasal Spray 0.1 mg/ml room temperature stable (RTS)/ Octostim® (desmopressin) Nasal Spray 1.5 mg/ml/ DDAVP® (desmopressin acetate, 10 mcg/0.1 mL)/ Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray/ Generic Desmopressin Acetate (10 mcg/0.1mL) Nasal Spray – Recall and Production Hold Statement
Following the detection of out-of-specification results during testing, in 2020 Ferring initiated a precautionary voluntary global recall of all batches of the following products:
- Minirin® (desmopressin) Nasal Spray 0.1 mg/ml room temperature stable (RTS) formulation
- Octostim® (desmopressin) Nasal Spray 1.5 mg/ml
- DDAVP® (desmopressin acetate, 10 mcg/0.1 mL)
- Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray
- Generic Desmopressin Acetate (10 mcg/0.1mL) Nasal Spray
Following an investigation, we have identified the underlying cause for the out of specification results as an issue with the tightness of the seal of the bottle.
To prevent a reoccurrence of this issue, Ferring intends to procure, install and qualify a new production line. Based on the timelines needed to complete these tasks, we anticipate that we will be able to restart manufacturing the products listed above in Q2 of 2023, with first deliveries to the market anticipated in the second half of 2023 (depending on the respective health authority approval).
Ferring is committed to ensuring that our medicines adhere to the highest quality standards for our patients. Please note that Ferring continues to manufacture the following desmopressin products. Availability varies by market.
- Minirin® (desmopressin) Nasal Spray 0.1 mg/ml Cold Storage Formulation
- Desmopressin Oral (tablet and oral lyophilizate) formulations
- Desmopressin Injectable formulations
In addition, other dosage forms of desmopressin acetate are available from other manufacturers.
Healthcare providers can contact their pharmacies and/or the manufacturers of these dosage forms for information about the availability of these alternatives.
Due to industry regulations, we cannot recommend alternative treatment options or provide medical advice directly to patients. Any patients or caregivers should contact their treating physician for advice about alternative treatment options.
If you have additional questions, please find contact details of regional Ferring teams below:
US and Canada
If you are based in the United States, please call our Medical Information line at 1-888-FERRING (1-888-337-7464) to discuss your question. You can also email MedQueriesUS@ferring.com.
If you are based in Canada, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.
Europe
If you are based in Europe, please contact info@ferring.com with your question and share your contact telephone number so that a member of your local team can contact you.
Asia-Pacific
If you are based in India, please contact medicaldesk.india@ferring.com and share your question and contact telephone number so that a member of the local team can contact you.
If you are based in other locations in Asia-Pacific, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.
Latin America
If you are based in Latin America, please contact info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.
Middle East and Africa
If you are based in the Middle East or Africa, please email info@ferring.com with your question and share your contact telephone number so that a member of the local team can contact you.