Product Recalls
Ikervis 1mg/ml Eye Drop Emulsion
Audiences
Consumer
Healthcare professional
Industry member
Product type
Therapeutic Products
30 September 2019
Retail-level recall of one batch of Ikervis 1mg/ml Eye Drop Emulsion, containing ciclosporin, due to a manufacturing issue that may result in the eye drop being less effective.
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Recall details
Date of recall: | 30 September 2019 |
|---|---|
Product: | Ikervis Eye Drop Emulsion 1mg/ml in a single-dose vial containing 0.3ml |
Active Ingredient: | Ciclosporin |
Product Category: | Therapeutic product |
Batch No.: | 6J11H |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Santen Pharmaceutical Asia Pte Ltd |
Description of Issue: | The company received feedback from patients that some of the single-use eye drops was found to be clear or colourless when it should have been a milky white emulsion. It was found that these eye drops have a lower amount of the active ingredient. This may result in the eye drop being less effective but there is no safety issue. The defect was due to a manufacturing issue that affected a small number of the eye drops from the affected batch. Ikervis is used to reduce eye inflammation in patients with severe dry eyes. Patents who use the affected eye drops may get lesser relief of their symptoms associated with severe dry eye syndrome. Patients who have concerns on their treatment can speak to their doctor. |
Recall Instructions: | Hospitals, clinics, pharmacies: Stop supplying the affected batch 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.