AvKARE因混药在全美主动召回西地那非100mg片剂和曲唑酮100mg片剂20201209
AvKARE Issues Voluntary Nationwide Recall of Sildenafil100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up
AvKARE因混药在全美主动召回西地那非100mg片剂和曲唑酮100mg片剂
AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to aproduct mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.
AvKARE, Pulaski, TN召回一批西地那非100mg片剂和一批曲唑酮100mg片剂至消费者层次。召回原因是在第三方工厂发生混药事件，导致两种药品无意间被包装在一起。
Product
Lot
Expiration date
Bottle count
NDC Number
Sildenafil Tablets, USP
36884
03/2022
100
42291-748-01
Trazodone Tablets, USP
36783
06/2022
1000
42291-834-10
Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment. To date, AvKARE has not received any reports of adverse events related to this recall.
非有意摄入西地那非可能会导致严重健康风险及其它隐藏的医疗问题。例如，西地那非可能会与一些处方药（如硝化甘油）中的硝酸盐发生反应，将血压降低至危险水平。有糖尿病、高血压或心脏病的患者通常会服用硝酸盐。非有意曲唑酮可能会导致不良心脏后果如嗜眠/镇定、头晕、便秘和视物不清。这些不良事件可能更容易发生在老年患者身上，因为后续会增加摔倒和驾驶障碍风险。截止目前，AvKARE尚未收到任何与此召回有关的不良事件报告。
Sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor, is used for the treatment of erectile dysfunction and is packaged in 100 count bottles, NDC 42291-748-01. Trazodone hydrochloride is indicated for the treatment of major depressive disorder and packaged in 1000 count bottles, NDC 42291-834-10. The affected lots of Sildenafil 100 mg Tablet (Lot 36884 with an expiration date of 03/2022) and Trazodone Hydrochloride 100 mg Tablet (Lot 36783 with an expiration date of 06/2022) were distributed to our distributors and wholesalers, and then further distributed nationwide.
西地那非是万艾可中的活性成分，它是PDE-5抑制剂，用于治疗勃起功能障碍（ED），以100片/瓶包装。NDC号为42291-748-01。盐酸曲唑酮标示为治疗抑郁症，包装为1000片/瓶，NDC号为42291-834-10。受影响的西地那非100mg片剂（批号为Lot36884，有效期为2022年3月）和盐酸曲唑酮100mg片剂（批号36783，有效期2022年6月）被销售至我们的分销商和批发商处，再进一步销售到全国。
AvKARE has notified its distributors andcustomers and is arranging for return of all recalled product of the listedlots. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE at 1-855-361-3993 or emailcustomerservice@avkare.comto arrange for the return of the product.
AvKARE已向销售商和患者发出通知，并安排将所有上述批号召回产品退货。持有上述召回药品的分销商请联系客户，服务电话1-855-361-3993或邮件customerservice@avkare.com安排退货事宜。
