Safety Alerts and Products Recalls
安 全 警 示 及 藥 物 回 收
25 NOVEMBER 2025
Recall of five batches of two products of Clarem tablets
The Department of Health (DH) today (25 November) endorsed a licensed drug wholesaler, Healthcare Pharmascience Limited (HCPS), to recall four batches (batch numbers: 109309, 111462, 119814, 122050) of the product, namely Clarem Tablets 250mg (Hong Kong Registration number: HK-66855) and a batch (batch number: 109392) of product, namely Clarem Tablets 500mg (Hong Kong Registration number: HK-66856) from the market as a precautionary measure due to the potential quality issue.
The DH received notification from HCPS that the overseas manufacturer of the products is recalling the above batches of Clarem tablets from the market because of misrepresentation of its active pharmaceutical ingredient (API) manufacturing site which is breaking the traceability of the supply chain of the API source. HCPS therefore is voluntarily recalling the affected batches from the market.
The above two products both contain clarithromycin in different strengths which are prescription medicines used for the treatment of bacterial infections. According to HCPS, the affected batches had been imported into Hong Kong and supplied to private doctors and pharmacies.
HCPS has set up a hotline 3472 8128 to answer related enquiries.
So far, the DH has not received any adverse reaction reports in connection with the products. The DH will closely monitor the recall.
Patients should not stop taking the products without talking to your doctors. If in doubt, please consult the healthcare professionals immediately.
-
Ends/ Tuesday, November 25, 2025
回收五個批次共兩款「Clarem 藥片」
衞生署今日(十一月二十五日)同意持牌藥物批發商凱健科研產品有限公司(凱健)採取預防措施,因可能有潛在質量問題,從市面回收四個批次(批號:109309, 111462, 119814 和 122050)名為「Clarem 250 毫克藥片」(香港註冊編號:HK-66855)的產品及一個批次(批號:109392)名為「Clarem 500 毫克藥片」(香港註冊編號:HK-66856)的產品。
衞生署接獲凱健通知,Clarem 藥片的海外製造商因應原料藥製造地點的不準確陳述而未能確保來源供應鏈的可追溯性,正回收受影響批次的Clarem 藥片。作為預防措施,凱健自願從市面回收上述批次產品。
上述兩款產品均含有不同劑量的Clarithromycin,是用於治療細菌感染的處方藥物。根據凱健提供的資料,上述受影響批次產品曾進口香港並供應予私家醫生及藥房。
凱健已設立熱線電話(3472 8128)解答相關查詢。
衞生署至今未有接獲上述批次產品有關的藥物不良反應報告。衞生署會密切監察回收情況。
曾使用上述產品的人士在未與醫生商討前不應自行停用。如有疑問,應立即徵詢醫護人員的意見。
-
完2025年11月25日(星期二)