Ferring Pharmaceuticals Inc. is initiating a precautionary voluntary recall of all batches of Stimate® Nasal Spray (desmopressin acetate) 1.5 mg/mL. During testing of a sample of desmopressin acetate nasal spray solution product marketed outside the US, a low volume was observed and the analysis of the solution from this sample generated an out-of-specification result concerning the desmopressin content (155% of the targeted amount). In addition, an elevated amount of benzalkonium chloride was determined (120% of the targeted amount).
A Health Hazard Safety Evaluation has been prepared by Ferring Pharmaceuticals. There is a reasonable probability that the use of, or exposure to, certain defective units of this product could pose a significant hazard and may cause adverse health consequences due to increased concentrations of desmopressin.
Below are the affected lots of Stimate® that were shipped to CSL Behring beginning on December 15, 2017.
Patients in possession of any vials from any of these lots should contact your Authorized Distributor’s Customer Service to facilitate a return to them. If a healthcare provider or patient has any questions they are encouraged to call CSL’s Medical Information line at 1-800-504-5434 or to email MedinfoNA@cslbehring.com.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to be notified directly about the latest recall or withdrawal of recombinant and plasma products. The system is confidential and time sensitive. It is administered by an independent third-party organization and is free of charge. To enroll in the PNS, please call (888) UPDATE-U or go online at http://www.patientnotificationsystem.org
This material is provided for your general information only. NHF does not give medical advice or engage in the practice of medicine. NHF under no circumstances recommends treatment for specific individuals and in all cases recommends that you consult your physician or local hemophilia treatment center before pursuing any course of treatment.