August 13, 2020
CSL Behring and Ferring Pharmaceuticals have announced additional information about a recent recall of lots of Stimate® that was originally issued July 21, 2020.
Stimate® Nasal Spray is owned and manufactured by Ferring Pharmaceuticals Inc., and is distributed and sold in the United States by CSL Behring. After further collaboration with the FDA, Ferring is now extending the recall to the consumer level. This product is being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were identified during routine testing.
The risks associated with higher than specified amounts of desmopressin relate to abnormally low level of sodium in the blood which could potentially lead to seizure, coma, and death. To date, Ferring has not received an increase in adverse event reports due to increased concentrations from users of the nasal spray. A single non-fatal adverse event potentially associated with this issue was reported in the US during the timeframe that the affected product was distributed.
Ferring is recalling all batches of Stimate® Nasal Spray. The table below provides detail for all impacted batches of Stimate® that were shipped to CSL Behring beginning on December 15, 2017.
This recall is to be conducted to the consumer level and is being conducted with the knowledge of the FDA.
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 email to MedinfoNA@cslbehring.com.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia and bleeding disorders.
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.