Recall of two batches of Minirin Nasal Spray (desmopressin) 0.1mg/ml (2.5ml)
Consumer-level recall of two batches (R14347H, R14347L) of Minirin Nasal Spray 0.1mg/ml (2.5ml) due to out of specification for active substance, desmopressin.
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Date:
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21 July 2020
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Product:
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Minirin Nasal Spray 0.1mg/ml (2.5ml) (SIN03760P)
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Active Ingredient:
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Desmopressin
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Product Category:
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Therapeutic product
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Batch No.:
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R14347H, R14347L
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Class of Recall:
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1
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Level of Recall:
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Consumer
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Local Company:
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Ferring Pharmaceuticals Pte Ltd
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Description of Issue:
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Out-of specification results where higher concentrations of the active substance, desmopressin, have been detected in the affected batches during testing. The affected batches are being recalled by the company.
Minirin is a prescription medicine used to control the production of urine in patients with central diabetes insipidus, a rare condition characterised by constant thirst and excessive urination, and also used as a diagnostic aid to examine kidney function. 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 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.
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Recall Instructions:
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Patients:
Patients taking the affected medicine are advised not to stop the medicine without discussing with their doctor as stopping treatment for central diabetes insipidus can result in increased urination, which can lead to dehydration and high sodium levels in the blood. Patients are advised to contact the healthcare provider from whom they have obtained their medicine to discuss alternative treatment options for their medical conditions, and inform their doctor if they are experiencing any side effects from taking the medicine.
Healthcare professionals:
Healthcare professionals are advised to contact patients who are taking the affected medicines for a review of their treatment options.
Hospitals, clinics, pharmacies:
Stop supplying the affected batches and return the remaining stocks to the company.
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Note:
The Health Sciences Authority (HSA) publishes information regarding recalls of health products supplied in Singapore. These product recalls may be conducted on a company’s own initiative or upon HSA request to remove products where there are issues with quality, safety or efficacy.
When a recall is initiated, it does not necessarily imply that a product is considered unsafe or is inefficacious. A recall can also be initiated to remove products with quality defects that does not impact safety or efficacy from the market so as to ensure that products registered in Singapore continue to meet the stringent regulatory standards stipulated by HSA.
Not all recalls will lead to press releases. However, when a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will issue a press release to inform members of public.
Class of recall
A recall is classified as Class 1 or Class 2 depending on the potential hazard of the issue.
- Class 1: For recalls of products with issues that can potentially cause serious adverse health outcomes or death.
- Class 2: For recalls of products with issues that would not likely cause serious adverse health outcomes.
Level of recall
The level of product recall will depend on the potential hazard of the affected product, extent of distribution and whether other mitigating measures can be taken to address the issue.
- Consumer level: Affected product or batch(es) recalled from patients and consumers as well as wholesale suppliers, retail suppliers, hospitals, clinics and pharmacies.
- Retail level: Affected product or batch(es) recalled from retail suppliers, hospitals, clinics and pharmacies as well as wholesale suppliers.
- Wholesale level: Affected product or batch(es) recalled from wholesale suppliers.
Healthcare professional, Therapeutic Products
Published:
Product Recalls