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


Nsikak
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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:

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

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 viapharmacovigilance@nafdac.gov.ng

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

Signed Management

Source: nafdac.gov.ng

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