Ferring Statement on Minirin®/Octostim®/DDAVP®/Stimate® (desmopressin) Nasal Spray
Saint-Prex, Switzerland – 21 June, 2022 – 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 investigation, the root cause of the out-of-specification results was identified as a tightness issue with the primary packaging materials.
In order to resolve this issue, new machinery is required and a new assembly process will need to be designed and validated. Based on the timelines needed to procure, install and qualify a new production line, we expect to start manufacturing Minirin® Nasal Spray Room Temperature Stable (RTS) 0.1 mg/ml and Octostim® (desmopressin) Nasal Spray 1.5 mg/ml in Q2 of 2023. Dependent on regulatory submission and approval timelines, deliveries to first markets are now expected from mid-2024 due to additional stability data required.
Ferring is committed to ensuring that our medicines adhere to the highest quality standards for our patients, and to working with health authorities to ensure alternatives for patients. Any patients or caregivers with concerns or questions about treatment alternatives should immediately contact their treating physician.
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.