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Ferring Pharma US Recalls Nasal Sprays Due To Superpotency

ferringpharma aug07 lt

Ferring Pharmaceuticals US is recalling various nasal sprays citing superpotency or amounts of desmopressin higher than specified, the U.S. Food and Drug Administration announced in a statement.

The recall involves all lots on the market of DDAVP Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE Nasal Spray 1.5 mg/mL.

According to the agency, 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.

Ferring identified the issue during routine testing. A single non-fatal adverse event potentially associated with the issue was reported in the US during the time of the affected product distribution.

The company has not received an increase in adverse event reports to date related to the recalled products.

Both DDAVP Nasal Spray and Desmopressin Acetate Nasal Spray are indicated as antidiuretic replacement therapy to manage central cranial diabetes insipidus, as well as the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.

Further, Stimate Nasal Spray is to treat patients with hemophilia A with Factor VIll coagulant activity levels greater than 5%, as well as patients with mild to moderate classic von Willebrand's disease (Type I) with Factor VIII levels greater than 5%.

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