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Recall Of DDAVP® Nasal Spray 10mcg/0.1ml, Desmopressin Acetate Nasal Spray 10mcg/0.1ml, STIMATE® Nasal Spray 1.5mg/ml Due To Superpotency

October 1, 2020,

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
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

Recommendations

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 via pharmacovigilance@nafdac.gov.ng

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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