|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.