HSA 公布 Clonotril（氯硝西泮）0.5 mg 片剂第 2 类零售级召回
Recall of Clonotril (Clonazepam) 0.5 Tablet 0.5 mg
HSA 公布 Clonotril（氯硝西泮）0.5 mg 片剂的召回信息，原因是在稳定性研究中出现超标结果。该召回定级为第 2 类、零售级，涉及注册号 SIN06410P 的 31 个批号，召回日期列为 2026 年 10 月 12 日。召回指示要求医院、诊所和药房停止供应受影响批号并将剩余库存退回公司，本地公司为 Goldplus Universal Pte Ltd。
公告列出受影响批号、第2类零售级定级与稳定性研究超标的原因，可供对照新加坡召回分级与退回流程。
Recall details
Date of recall: | 12 October 2026 |
Product: | Clonotril 0.5 Tablet 0.5 mg |
Active Ingredient: | Clonazepam |
Product Category: | Therapeutic Product |
Registration Number: | SIN06410P |
Batch No.: | 99976 101777 101306 102820 103832 103833 104001 104377 106113 106114 106121 106539 107367 108506 108507 108508 109885 109886 110852 111227 112050 112287 114170 115066 115067 116357 118192 118294 118301 118747 118749 |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Goldplus Universal Pte Ltd |
Description of Issue: | Out-of-specification results in stability study |
Recall Instructions: | Hospitals, clinics, pharmacies: Stop supplying the affected batches 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