July 21, 2020

Ferring Pharmaceuticals has issued a voluntary recall of all Stimate® (desmopressin acetate) nasal spray 1.5mg/mL distributed and sold by CSL Behring LLC. It is possible that the product may contain elevated amounts of desmopressin acetate, the active pharmaceutical ingredient, and benzalkonium chloride, a preservative.

The concern arises from a tested sample of a desmopressin acetate nasal spray marketed outside of the United States. Analysis of the sample showed that it contained 155% of the intended desmopressin acetate content and 120% of the targeted benzalkonium chloride content. Ferring believes there is reasonable probability that use of or exposure to defective units of Stimate could pose a significant health hazard and lead to adverse drug events.

Stimate is indicated to stop bleeding in certain patients diagnosed with hemophilia A or von Willebrand disease type 1. There are currently no generic alternatives. However, other formulations of desmopressin acetate are available for patients who have these bleeding disorders.

Questions regarding the recall should be directed to CSL Behring Medical Information at 1-800-504-5434 or MedinfoNA@cslbehring.com. A copy of the recall notice can be found here.

There is minimal member impact at Benecard Central Fill, and the affected members have been contacted.

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