Recall of Two Batches (R14347H, R14347L) of Minirin Nasal Spray due to Detection of Higher Concentration of Active Ingredient

The Health Sciences Authority (HSA) is overseeing the recall of two batches of Minirin Nasal Spray 10mcg/dose marketed by Ferring Pharmaceuticals Pte Ltd. Some of the products in these two batches have been detected to contain a higher concentration of the active ingredient, desmopressin. The other batches of this product are not affected by this recall. Please refer to Table A for the affected batch numbers and Annex A of the pdf version for pictures of the medicine.

Table A: Recalled batches of Minirin Nasal Spray

Batch Number

Expiry

R14347H

July 2022

R14347L

July 2022

 

2        Minirin Nasal Spray is a prescription-only medicine used to control the production of urine in patients with central diabetes insipidus (CDI), a rare condition characterised by constant thirst and excessive urination, and also used as a diagnostic aid to examine kidney function.

3        The risk of experiencing serious side effects with the use of the affected batches is low in most patients as patients are generally trained to monitor and adjust their dose according to the symptoms they experience. In situations where the patients are not able to adjust the dose properly, they may experience symptoms of overdose such as decreased thirst and urination, headache, nausea, vomiting and muscle spasms, due to water retention and low sodium levels in the blood.

4        Healthcare institutions affected by the recall of the product have been informed by Ferring Pharmaceuticals Pte Ltd, and healthcare professionals have been advised to contact patients who had been prescribed the affected batches of medicine, for a review of their treatment options.

5        Patients are advised to check the batch number on their product. Those who are using the affected batches of Minirin Nasal Spray are advised to:          

  • Contact the healthcare provider from whom they have obtained their medicine to discuss alternative treatment options for their medical conditions. Inform their doctor if they are experiencing any side effects from taking the medicine.
  • Do not stop using the medicine without discussing with their doctor as stopping treatment for CDI can result in increased urination, which can lead to dehydration and high sodium levels in the blood. Patients who are concerned about their current treatment can speak to their doctor or pharmacist.

6        For further enquiries, members of the public can contact Ferring Pharmaceuticals Pte Ltd at their hotline: 6812 7526.

HEALTH SCIENCES AUTHORITY
SINGAPORE
24 JULY 2020

Download pdf version here354 KB

Consumer, Healthcare professional, Industry member, Therapeutic Products
Published:

HSA Updates

24 Jul 2020