Recall of DDAVP® Nsal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency
The National Agency for Food and Drug Administration and Control has received information from the US FDA that Ferring Pharmaceuticals US is voluntarily recalling all lots of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.
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.
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.
DDAVP® Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
Desmopressin Acetate Nasal Spray is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region.
Stimate® Nasal Spray is indicated for the treatment of patients with haemophilia A with Factor VIII coagulant activity levels greater than 5% and for treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.
Affected Products Details:
|Lot||Exp Date||NDC #|
|DDAVP® Nasal Spray 10 mcg/0.1 mL, 5 mL|
|Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL|
|Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL|
Healthcare professionals are encouraged to:
- Stop dispensing or distributing the above products immediately and remove from the shelves within your store.
- Return unused products to their nearest NAFDAC office for regulatory action
NAFDAC implores all importers, wholesalers, and retailers to immediately stop the importation, distribution, and use of the recalled products.
Patients and healthcare providers are advised to report adverse events and quality problems they experienced using these products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or firstname.lastname@example.org