HSA 因片剂出现黑点召回 Tetrabenazine 25mg 112's Sun-Italy 批次 DNG1035A
Recall of Tetrabenazine 25mg 112’s Sun-Italy
HSA 于 2026 年 10 月 27 日召回 Tetrabenazine 25mg 112's Sun-Italy 批次 DNG1035A，属二级召回，原因为片剂表面出现黑点，并以预防措施名义执行。本地公司 Alliance Pharm Pte Ltd 负责此次召回，召回层级为零售层级。医院、诊所与药房须停止供应受影响批次，并将剩余库存退回该公司。
Recall details
Date of recall: | 27 October 2026 |
Product: | Tetrabenazine 25mg 112’s Sun-Italy |
Active Ingredient: | Tetrabenazine |
Product Category: | Therapeutic Product |
Batch No.: | DNG1035A |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Alliance Pharm Pte Ltd |
Description of Issue: | Presence of black spots on the tablets. 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