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Drug Safety Alerts
STIMATE® Nasal Spray Consumer-Level Recall
8/12/2020
On August 12, 2020, CSL Behring issued a consumer-level recall of all lots on the market of STIMATE® Nasal Spray 1.5 mg/mL NDC # 00053-6871-00 manufactured by Ferring Pharmaceuticals and distributed and sold by CSL Behring. This recall was issued due to superpotency or amounts of desmopressin higher than specified.
This may represent a potential health hazard or safety risk to patients using product affected by this recall.
The risks associated with higher than specified amounts of desmopressin relate to abnormally low levels of sodium in the blood (i.e., hyponatremia) which could eventually lead to seizure, coma, and death. To date, Ferring reports that it has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray, but that 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.
STIMATE® Nasal Spray 1.5 mg/mL is indicated for the treatment of patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%.
Previously on August 5, 2020, the United States Food and Drug Administration (FDA) published a notice about a consumer-level recall of all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL manufactured by Ferring Pharmaceuticals, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL manufactured by Ferring Pharmaceuticals and distributed by Amring Pharmaceuticals and STIMATE® Nasal Spray 1.5 mg/mL manufactured by Ferring Pharmaceuticals and distributed by CSL Behring.
CVS Caremark Response:
Please note: STIMATE® Nasal Spray 1.5 mg/mL is not carried by the CVS Caremark® Mail Service Pharmacies.
For more information about this recall, please contact CSL Behring Medical Information at 1‑800-504-5434 or visit https://www.ferringusa.com.
You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.