Product Recalls
Recall of Neuronox Lyophilized Powder for Injection 100 units/vial
Audiences
Healthcare professional
Product type
Therapeutic Products
7 July 2020
Retail-level recall of Neuronox Lyophilized Powder for Injection 100 units/vial due to potential quality issue.
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Recall details
Date: | 7 July 2020 |
|---|---|
Product: | Neuronox Lyophilized Powder for Injection 100 units/vial (SIN15692P) |
Active Ingredient: | Clostridium Botulinum Type A Toxin – Haemagglutinin Complex |
Product Category: | Therapeutic product |
Batch No.: | All batches |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Fondaco Pte Ltd |
Description of Issue: | The product may potentially have some quality issues which does not affect the safety of the product. However, as a precautionary measure, the company is voluntarily recalling the product from the market. Neuronox is a prescription medicine used to several medical condition including facial dystonia (muscles contracting involuntarily) and muscle spasticity (muscle stiffness). |
Recall Instructions: | Hospitals, clinics, pharmacies: Stop supplying the affected batches and return the remaining stocks to the company. |
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.