Recall of six batches of Aprovel Film-Coated Tablet 150MG, Coaprovel Film-Coated Tablet 150/12.5MG and Coaprovel Film-Coated Tablet 300/12.5MG
Retail-level recall of several batches of Aprovel Film-Coated Tablet 150MG, Coaprovel Film-Coated Tablet 150/12.5MG and Coaprovel Film-Coated Tablet 300/12.5MG, containing irbesartan, due to impurity above acceptable level
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Date of recall:
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28 October 2021
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Product:
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- Aprovel Film-Coated Tablet 150MG
- Coaprovel Film-Coated Tablet 150/12.5MG
- Coaprovel Film-Coated Tablet 300/12.5MG
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Active Ingredient:
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Irbesartan
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Product Category:
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Therapeutic product
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Batch No.:
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Please refer to Annex for the batch numbers.
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Class of Recall:
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2
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Level of Recall:
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Retail
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Local Company:
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Sanofi-Aventis Singapore Pte. Ltd
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Description of Issue:
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During recent testing, an impurity, [5-(4’-(azidomethyl)-[1,1’-biphenyl]-2-yl)-1H-tetrazole], was found to be above the acceptable level in several batches of Aprovel Film-Coated Tablet 150MG, Coaprovel Film-Coated Tablet 150/12.5MG and Coaprovel Film-Coated Tablet 300/12.5MG. As a precautionary measure, the affected batches are recalled.
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Recall Instructions:
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Hospitals, clinics, pharmacies:
Stop supplying the affected batch and return the remaining stocks to the company.
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Annex
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Product Name
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Batch Number
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Aprovel Film-Coated Tablet 150MG
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AA365
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Coaprovel Film-Coated Tablet 150/12.5 mg
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AA557
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Coaprovel Film-Coated Tablet 300/12.5 mg
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AA510
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Coaprovel Film-Coated Tablet 300/12.5 mg
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AA549
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Coaprovel Film-Coated Tablet 300/12.5 mg
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AA552
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Coaprovel Film-Coated Tablet 300/12.5 mg
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AA527
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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