藥物警訊（藥師週刊 第1709期）

Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials

AUDIENCE: Hospital Risk Managers, Pharmacy, Emergency Medicine

Cumberland Pharmaceuticals Inc. recalled 6 lots of Acetadote（acetylcysteine）Injection, 20% solution（200mg/mL）in 30 mL single dose glass vials as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier.

BACKGROUND: Used in the emergency department, Acetadote is administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. This product was distributed to U.S. wholesalers and distributors nationwide, please refer to the firm press release for lot numbers being recalled.

RECOMMENDATION: 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 complete MedWatch 2011 Safety summary, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

Cumberland製藥公司預防性回收6批Acetadote（acetylcysteine）Injection, 20% solution（200 mg/mL）30 mL單一劑量玻璃瓶針劑，因為在少數產品中發現顆粒雜質，此雜質可能是來自玻璃瓶製造過程。

Acetadote在急診用於服用可能造成肝毒性劑量的acetaminophen後8-10小時內經注射投與，以預防或減少肝臟傷害，此產品經全美批發商及經銷商販售，回收產品批號為090304（有效期限2011年2月）、090331（有效期限2011年2月）、090401（有效期限2011年3月）、090511（有效期限2011年4月）、090602（有效期限2011年5月）及090616（有效期限2011年5月）。

相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238494.htm
[Posted 01/01/2011]

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