Drug Safety Alerts

Desmopressin Acetate Nasal Spray 10 mcg/0.1mL Consumer-Level Recall

8/11/2020

On August 11, 2020, Amring Pharmaceuticals issued a notice about a consumer-level recall of all lots on the market of Desmopressin Acetate Nasal Spray 10 mcg/0.1mL NDC # 69918-0501-05 manufactured by Ferring Pharmaceuticals for Amring Pharmaceuticals. 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 advised that it 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.

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.

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.

Amring advises that patients or their caregivers should contact their healthcare providers immediately to discuss next steps and treatment options before stopping their current medication.

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 Desmopressin Acetate Nasal Spray 10 mcg/0.1mL to contact their prescriber.

For more information about the Amring Medical Information at 1-844-267-4641, Monday through Friday, 9:00 am to 5:00 pm (ET) or visit https://www.ferringusa.com.

You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.