ST LOUIS (MD Consult) - On October 20, 2009, American Regent and the US Food and Drug Administraion announced a voluntary recall of all lots of injectable Ketorolac Tromethamine in 30 mg/ml strengths, packaged in 1- and 2-ml single-dose vials (30 mg/ml 1ml and 60 mg/2ml). The recall, which was initiated October 16, 2009, is being implemented because a potential exists that particulate matter in conjunction with crystallization may be present in the product.

 

According to the package insert, Ketorolac Tromethamine for injection is a nonsteroidal antiinflammatory drug (NSAID) that is indicated for the short-term management of moderately severe acute pain that requires analgesia at the opioid level.

American Regent is undertaking this recall in consideration of the potential for safety issues if the product is administered to patients. Potential adverse reactions that could occur include obstruction of blood vessels that could induce pulmonary emboli or thrombosis, and activation of platelets and/or neutrophils that could induce anaphylactic reactions. Other adverse effects associated with the injection of particulate matter include foreign body granulomas and local irritation at the injection site.

As is standard practice, and as stated in the Ketorolac Tromethamine injection product package insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit". American Regent reminds health care professionals to adhere to this practice.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent via email at PV@luitpold.com, by telephone at 1-800-734-9236, or by fax to 610-650-7781 or 610-650-0170.

 

圣路易斯(MD Consult)——2009年10月20日，美国Regent实验室和美国食品药品管理局宣布自愿召回所有批次的规格为30 mg/ml的1-ml和2-ml(30 mg/1ml 和 60 mg/2ml)单次用量瓶装酮咯酸氨丁三醇注射剂。这次召回始于2009年10月16日，目前正在实施，其原因是产品中可能出现与结晶作用相关的颗粒物质。

根据药品说明书，酮咯酸氨丁三醇注射剂为一种非甾体类抗炎药物(NSAID)，其被用于短期控制那些需阿片类药物止痛的中重度急性疼痛。

美国Regent实验室正在实施召回，以防患者使用该产品后出现安全性问题。可能发生的不良反应包括血管阻塞引起的肺栓塞或血栓形成以及血小板和/或中性粒细胞活化导致过敏反应。其他与颗粒物质注射相关的不良反应包括异物肉芽肿和注射部位局部刺激。

 

根据标准惯例以及酮咯酸氨丁三醇注射剂产品说明书所述，"胃肠外给药的药物在使用前，如果溶液和容器允许，应先肉眼检查是否有颗粒物质和变色现象。"美国Regent实验室提醒医务工作者应遵守这一惯例。

 

如发生任何与该产品使用相关的不良反应和/或质量问题，请向美国Regent实验室报告，电子邮箱：，电话：1-800-734-9236，传真：610-650-7781或610-650-0170。