新加坡HSA对DANTRIUM 20 mg注射用粉末批号80681启动1级召回
Recall of DANTRIUM 20 mg Powder for Solution for Injection
新加坡HSA于2026年10月20日发布DANTRIUM 20 mg Powder for Solution for Injection批号80681的1级召回，召回层级为零售层级。召回原因是药瓶内存在可见异物，受影响批次作为预防措施被召回。公告要求医院、诊所和药房停止供应该批次，并将剩余库存退回本地公司Alliance Pharm Pte Ltd。
公告列出批号、1级与零售层级召回范围，并说明注射剂瓶内可见异物触发的预防性召回缘由。
Recall details
Date of recall: | 20 October 2026 |
Product: | DANTRIUM 20 mg Powder for Solution for Injection |
Active Ingredient: | Dantrolene |
Product Category: | Therapeutic Product |
Batch No.: | 80681 |
Class of Recall: | 1 |
Level of Recall: | Retail |
Local Company: | Alliance Pharm Pte Ltd |
Description of Issue: | Presence of visible foreign particulate matter in the vials. The affected batch is recalled as a precautionary measure. |
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 be publicly announced via press releases. When a recall involves a product that has been widely distributed or a product that poses a serious health risk, HSA will update the public through its channels, which may include its website, social media platforms or a press release.
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