新加坡卫生科学局（HSA）召回氟脱氧葡萄糖 F-18 注射液批次 260819-01F
Recall of Fludeoxyglocuose F-18 Injection 5 - 20mCi/ml
新加坡卫生科学局（HSA）公布召回 Positron Tracers Pte. Ltd. 的氟脱氧葡萄糖 F-18 注射液 5-20mCi/ml，召回日期为 2026 年 8 月 19 日。涉及批次 260819-01F，注册号 SIN12598P，原因为放射性化学纯度质量控制检验不合格。该召回定为 Class 2、零售层级，召回说明要求医院和诊所停止供应受影响批次，并进行隔离和处置。
材料列出召回批次、注册编号与召回级别，可对照了解新加坡零售层级召回所涉产品及处置说明的具体范围。
Recall details
Date of recall: | 19 August 2026 |
Product: | Fludeoxyglocuose F-18 Injection 5 - 20mCi/ml |
Active Ingredient: | Fluoro-2-deoxy-d-glucose |
Product Category: | Therapeutic product |
Registration Number: | SIN12598P |
Batch No.: | 260819-01F |
Class of Recall: | 2 |
Level of Recall: | Retail |
Local Company: | Positron Tracers Pte. Ltd. |
Description of Issue: | Failed radiochemical purity quality control test |
Recall Instructions: | Hospitals, clinics Stop supplying the affected batch, to isolate and dispose. |
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