Nasal Spray Recall

Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency.

Company Announcement

Ferring Pharmaceuticals US is voluntarily recalling 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 listed in the table below 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. 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.

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 hemophilia A with Factor VIll coagulant activity levels greater than 5%.

Stimate® Nasal Spray is indicated for the treatment of patients with mild to moderate classic von Willebrand’s disease (Type I) with Factor VIII levels greater than 5%.

Ferring US is notifying its distributors and wholesale customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter. The affected product name, including the batch numbers and expiration dates, include:

LotExp DateNDC #
DDAVP® Nasal Spray 10 mcg/0.1 mL, 5 mL
N14695F08 202055566-2500-0
N15627C10 202055566-2500-0
P11319P01 202155566-2500-0
P11706F04 202155566-2500-0
R11842C03 202255566-2500-0
R13637E06 202255566-2500-0
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL
N14695P08 202069918-501-05
N14695S08 202069918-501-05
N15627G10 202069918-501-05
N15627GA10 202069918-501-05
P10422A01 202169918-501-05
P10422AA01 202169918-501-05
P10430G03 202169918-501-05
P11319M01 202169918-501-05
P12969H05 202169918-501-05
P12969IR05 202169918-501-05
P13216G05 202169918-501-05
P13216P05 202169918-501-05
R11842A03 202269918-501-05
R11842S03 202269918-501-05
R12630A05 202269918-501-05
R13071H04 202269918-501-05
Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL
N14134C07 20200053-6871-00
N15378G09 20200053-6871-00
N17445N12 20200053-6871-00
P11326AA02 20210053-6871-00
P11326C02 20210053-6871-00
P13209L04 20210053-6871-00
P13212H06 20210053-6871-00
P13755A06 20210053-6871-00
P13756P08 20210053-6871-00
R11845A04 20220053-6871-00
R13271A04 20220053-6871-00
R13648A06 20220053-6871-00
R14101A07 20220053-6871-00
R14667A08 20220053-6871-00
R15953C09 20220053-6871-00

Distributors/wholesalers with questions regarding the recall should call Stericycle at 1-888-228-5053.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information

Consumers: 1-888-337-7464, Media:Patrick Gorman (862) 286-5035,  patrick.gorman@ferring.com

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