藥物警訊（藥師週刊 第1712期）

Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination

Sold by Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, Conzellin

AUDIENCE: Pharmacy, Consumer

Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of?alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.

BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.

RECOMMENDATION: If a consumer has any of these types of products in their possession listing "Triad Group" as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a linl to the Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Triad Group (非處方藥製造藥廠)及FDA提醒醫療人員及病人回收所有批號Triad製造而以其它自有品牌販售的酒精棉片(alcohol prep pads、alcohol swabs及alcohol swabsticks)，此次回收是考量到產品有潛在被仙人掌桿菌污染的風險，包含市售滅菌和未滅菌的產品，使用受到汙染的酒精棉片可能導致威脅生命的感染，尤其是感染高風險的族群，包含免疫低下及術後病人。

酒精棉片用於注射前消毒，以每片單一包裝，每盒100片在全美、加拿大及歐洲零售藥局販售，無論製造商標示為Triad Group，或是包裝上標示Cardinal Health、PSS Select、VersaPro、Boca/ Ultilet、Moore Medical、Walgreens、CVS或Conzellin的產品皆須回收。FDA建議持有上述產品製造商標示為Triad Group的消費者，產品不應使用且應立即退回購買處退費。

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm
[Posted 01/06/2011]

資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部