新加坡 HSA 召回 Remethan 100 R 片剂 100 mg（批号 104024）
Recall of Remethan 100 R Tablet 100 mg
新加坡 HSA 于 2026 年 7 月 10 日召回 Remethan 100 R 片剂 100 mg（批号 104024，活性成分双氯芬酸钠），召回级别为 2 级、零售层面。召回原因为稳定性批次检验结果不符合规定。HSA 要求医院、诊所和药房停止供应受影响批次，并将剩余库存退回本地公司 Goldplus Universal Pte Ltd。
材料列出召回批号、级别与召回原因，说明稳定性批次检验结果不符合规定，便于核对受影响产品范围。
Recall details
Date of recall: | 10 Jul 2026 |
Product: | Remethan 100 R Tablet 100 mg |
Active Ingredient: | Diclofenac Sodium |
Product Category: | Therapeutic Product |
Batch No.: | 104024 |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Goldplus Universal Pte Ltd |
Description of Issue: | Out-of-specification results in stability batches |
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’s 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.
来源：HSA 治疗药品召回 · hsa.gov.sg