Drug Safety Alerts

DDAVP® Nasal Spray 10 mcg/0.1mL Consumer-Level Recall

8/11/2020

On August 11, 2020, Ferring Pharmaceuticals issued a consumer-level recall of all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL NDC # 55566-2500-00. This recall was issued due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.

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 has not received an increase in adverse event reports due to increased concentrations of desmopressin from users of the nasal spray. 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.

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: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using DDAVP® Nasal Spray 10 mcg/0.1mL to contact their prescriber.

For more information about this recall, please contact Ferring at 1-888-337-7464, Monday through Friday 8:00AM through 5:30 PM (ET) and select option #2 or visit https://www.ferringusa.com.

You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.