Ferring Pharmaceuticals has provided an update to HFA and NHF regarding the availability of Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray (“Stimate”).Â
The letter addresses the investigation completed by Ferring; the investigation determined that the “underlyingÂ cause for the out-of-specification results as an issue with the tightness of the seal of the bottle.” Furthermore, the letter indicates “Ferring intends to procure, install and qualify a new production line. Based on the time required to complete these tasks, we anticipate that we will be able to restart manufacturing of Stimate® (desmopressin acetate, 1.5 mg/1 mL) Nasal Spray in Q2 of 2023. Contingent on FDA approval, we estimate first deliveries to the market will be possible in the second half of 2023.”
To read the letter in full, click here.
HFA reminds you to please reach out to your physician with any medical concerns.Â You can also contact CSL Behring’s Medical Information Phone Line at 1-800-504-5434.
Please note that HFA does not recommend, endorse or make any representation about the efficacy, appropriateness or suitability of any specific products, treatments or opinions. If you have any questions or concerns about your medical treatment, including your possible exposure to recalled product, please consult your physician.Â