Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Superpotency
Company Name:
Ferring Pharmaceuticals US
Brand Name:
Ferring, Amring, CSL Behring
Product Description:
DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL

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:

Lot Exp Date NDC #
DDAVP® Nasal Spray 10 mcg/0.1 mL, 5 mL
N14695F 08 2020 55566-2500-0
N15627C 10 2020 55566-2500-0
P11319P 01 2021 55566-2500-0
P11706F 04 2021 55566-2500-0
R11842C 03 2022 55566-2500-0
R13637E 06 2022 55566-2500-0
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5 mL
N14695P 08 2020 69918-501-05
N14695S 08 2020 69918-501-05
N15627G 10 2020 69918-501-05
N15627GA 10 2020 69918-501-05
P10422A 01 2021 69918-501-05
P10422AA 01 2021 69918-501-05
P10430G 03 2021 69918-501-05
P11319M 01 2021 69918-501-05
P12969H 05 2021 69918-501-05
P12969IR 05 2021 69918-501-05
P13216G 05 2021 69918-501-05
P13216P 05 2021 69918-501-05
R11842A 03 2022 69918-501-05
R11842S 03 2022 69918-501-05
R12630A 05 2022 69918-501-05
R13071H 04 2022 69918-501-05
Stimate® Nasal Spray 1.5 mg/mL, 2.5 mL
N14134C 07 2020 0053-6871-00
N15378G 09 2020 0053-6871-00
N17445N 12 2020 0053-6871-00
P11326AA 02 2021 0053-6871-00
P11326C 02 2021 0053-6871-00
P13209L 04 2021 0053-6871-00
P13212H 06 2021 0053-6871-00
P13755A 06 2021 0053-6871-00
P13756P 08 2021 0053-6871-00
R11845A 04 2022 0053-6871-00
R13271A 04 2022 0053-6871-00
R13648A 06 2022 0053-6871-00
R14101A 07 2022 0053-6871-00
R14667A 08 2022 0053-6871-00
R15953C 09 2022 0053-6871-00

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.

Read the full FDA report here.
As published by HealthyExaminer.com