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Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials
AUDIENCE: Family Practice, Pharmacy, Consumer
The Ritedose Corporation is conducting a voluntary recall of 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials. This product is being recalled because the 2.5 mg/3 mL single use vials are embossed with the wrong concentration of 0.5 mg/ 3 mL and therefore, represents a potential significant health hazard. Only the unit dose vials are incorrectly embossed as containing 0.5 mg/3 mL. The correct concentration of 2.5 mg/3 mL is labeled on the primary foil overwrap pouches and shelf cartons. Administration of this defective product could result in a range of potential health effects that spans from temporary and medically reversible to life threatening and death.
There is significant concern that health professionals who read the incorrect embossed concentration may upwardly adjust the volume of product used resulting in an administered amount that is 5 times the recommended dose. In the hospital setting, the vials are often not accompanied by the rest of the packaging, making it more likely that such a dosing error could occur. Significant overdosing of a patient could lead to signs and symptoms of albuterol toxicity, which includes tremors, dizziness, nervousness, headache, seizures, angina, high blood pressure, low potassium levels, and rapid heart rates up to 200 beats/minute.
BACKGROUND: This product is a prescription inhalation solution, administered via nebulization, for the treatment and maintenance of acute asthma exacerbations and exercise induced asthma in children and adults. The product is packaged as a single use unit dose vials in a protective foil overwrap packaged in a shelf carton. The following lot numbers manufactured by The Ritedose Corporation under NDC: 0591-3797-83, 0591-3797-30, and 0591-3797-60 are included in the recall: 0N81, 0N82, 0N83, 0N84, 0NE7, 0NE8, 0NE9, 0NF0, 0P12, 0P13, 0P46, 0P47, 0PF0, and 0S15. No other Albuterol formulations or products are included in this recall. This product was distributed nationwide and Puerto Rico.
RECOMMENDATION: Consumers should immediately return the affected product to the place it was obtained (i.e. doctor’s office, pharmacy, etc.). Wholesalers and retailers should return the product to the address stated in the firm Press Release.
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 link to the company press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
Ritedose公司自願性回收0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25, 30, and 60 unit dose vials，因為2.5 mg/3 mL的產品標示成錯誤的濃度0.5 mg/ 3 mL，雖然僅在單一劑量包裝上標示錯誤，外層的鋁箔包裝及紙盒標示皆正確，然而，投與此缺陷產品可能對健康造成潛在的危害。
醫療人員若看到錯誤的標示可能會增加給藥的體積，而造成給予原建議的五倍劑量，尤其在醫院，此呼吸溶液劑常以單一劑量包裝調配，醫療人員不一定會看到標示正確的其他外包裝，而更容易造成上述錯誤，若藥物過量可能會造成albuterol毒性，如：顫抖、暈眩、緊張、頭痛、癲癇、心絞痛、高血壓、低血鉀及心跳過速到每分鐘200下。
此產品為吸入型溶液，經霧化器給藥，用於治療或維持孩童及成人急性氣喘惡化及運動誘發型氣喘，此產品為單一使用劑量包裝，數個呼吸溶液劑外層以鋁箔包裝，最後以紙盒包裝成每盒25支、30支或60支。回收產品NDC: 0591-3797-83、0591-3797-30及0591-3797-60批號為0N81、0N82、0N83、0N84、0NE7、0NE8、0NE9、0NF0、0P12、0P13、0P46、0P47、0PF0及0S15，在全美及波多黎各販售。
FDA建議消費者，應立即將回收產品，退回給醫師辦公室或藥局等處，批發商及零售商應將回收產品退回Ritedose公司。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238624.htm
[Posted 01/03/2011]
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
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資料來源：藥師週刊 第1710期