Recall of one batch of Dotarem Injection 27.932g/100ml
Retail-level recall of one batch of Dotarem Injection 27.932g/100ml containing gadoteric acid, due to quality defect leading to potential external leakage.
|
Date of recall:
|
25 November 2021
|
|
Product:
|
Dotarem Injection 27.932g/100ml
|
|
Active Ingredient:
|
Gadoteric Acid
|
|
Product Category:
|
Therapeutic product
|
|
Batch No.:
|
20GD075B
|
|
Class of Recall:
|
1
|
|
Level of Recall:
|
Retail
|
|
Local Company:
|
Transmedic Pte Ltd
|
|
Description of Issue:
|
During sample inspection, some vials had evidence of external leaks of the solution (dry product on the external surface of the vials). This is due to the defect of the neck of the glass vials supplied.
|
|
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.
Healthcare professional, Therapeutic Products
Published:
Product Recalls