Kespol 75% Ethanol Solution — Cleaning, Disinfection and Sterilization Liquid | Medical Product Recall 110.1

On January 5, 2021 (ROC year 110), the Food and Drug Administration of the Ministry of Health and Welfare of the Republic of China issued a “Class II recall” drug recall notice concerning “Kespol 75% Ethanol Solution,” a skin and hand cleaning, disinfection and sterilization product (200 ml bottle) sold by Golden Spirit Enterprise Co., Ltd. exclusively through medical institution channels. After the manufacturer voluntarily reported that the drug in the affected batch was found in its 12th-month ongoing stability test to have impurity levels exceeding the originally approved specification, the product was voluntarily recalled following evaluation.

The FDA has required the manufacturer to complete the recall by January 24, 2021 (ROC year 110) and to submit a recall results report and follow-up corrective and preventive actions. At the same time, all medical institutions, pharmaceutical firms and pharmacies must cooperate with the recall and immediately stop dispensing and supplying the product.

Basic Information on the Recalled Drug

• Drug / Product name: Kespol 75% Ethanol Solution.
• Indication: For cleaning, disinfection and sterilization of skin and hands.
• Active ingredient: ALCOHOL 95% (EQ TO ETHANOL 95%).
• Special scents: Original, floral.
• Packaging: 5 L, 10 L and 20 L plastic bottles, as well as plastic bottles of 4,000 ml or less.
• Drug permit number: Wei-Shu Cheng-Chih Tzu No. 014771.
• Batch numbers: 401A0090, 401A0220, 402A0160.
• Permit holder: (620203A186) Golden Spirit Enterprise Co., Ltd. Address: No. 232, Dazhong 2nd Rd., Zuoying District, Kaohsiung City, Taiwan, Republic of China;
• Contact phone: 0800589797.

Main manufacturer: (6143060106) Medical Strong Technology Co., Ltd.

• Address: No. 27, Nongyuan Rd., Dehe Village, Changzhi Township, Pingtung County, Taiwan, Republic of China

Reference photo of the drug:

Kespol 75% Ethanol Solution

Drug Recall Information

• Recall classification[1]: II.
• Recall document number: FDA Drug Tzu No. 1091413537 dated December 25, 2020 (ROC year 109) (Drug Division, FDA).
• Date of issuance: December 25, 2020 (ROC year 109).
• Date of publication: January 5, 2021 (ROC year 110).
• Reason for recall: The manufacturer voluntarily reported that the drug in the affected batch was found in its 12th-month ongoing stability test to have impurity levels exceeding the originally approved specification.

References

1. Introduction to the “Drug Recall Classification System” and Handling Measures by the FDA, Ministry of Health and Welfare.
2. Query of permits for Western medicines, medical devices and cosmetics