| Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling
AUDIENCE: Pharmacy, Patient
An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Both products are manufactured by Qualitest Pharmaceuticals.
As a result of this mix-up, patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid na?ve patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
BACKGROUND: The recall includes the following products:
* Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
* Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
Recalled lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).
RECOMMENDATION: Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement.? Lot numbers can be found on the side of the bottle.
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...
FDA發佈回收訊息，Qualitest製藥公司自願性回收，因為內含hydrocodone bitartrate及acetaminophen的錠劑，USP 10 mg/500 mg，NDC 0603-3888-20，60錠單一瓶裝，瓶標錯誤標示成phenobarbital錠劑，USP 32.4 mg，NDC 0603-5166-32，1000錠裝，批號T150G10B，兩種產品皆為Qualitest製藥公司製造。
此錯誤可能造成原本需服用phenobarbital的病人卻服用hydrocodone bitartrate及acetaminophen，意外服用hydrocodone可能會導致嚴重的不良反應事件，包含呼吸抑制、中樞抑制、昏迷及死亡，尤其是首次接觸鴉片類藥品的病人及服用其他中樞抑制劑的病人，而服用其他acetaminophen製劑、有肝功能不良或一天飲用超過3瓶酒精性飲料的病人，意外服用acetaminophen可能會造成肝毒性，再者，未服用phenobarbital可能造成病人癲癇失控。
回收的產品如下：
* Hydrocodone Bitartrate and Acetaminophen Tablets，USP 10 mg/500 mg，NDC 0603-3888-20，60錠裝，批號T150G10B、T120J10E及T023M10A
* Phenobarbital Tablets，USP 32.4 mg，NDC 0603-5166-32，1000錠裝，批號T150G10B、T120J10E及T023M10A
回收批號為2010/9/21至2010/12/29銷售至全美包含波多黎各的批發商及零售商。FDA建議持有回收產品的消費者應停止使用並與Qualitest製藥公司聯絡相關回收事宜。
相關訊息與連結請參考FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 02/07/2011]
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 |
資料來源：藥師週刊 第1716期
