ST LOUIS (MD Consult) - ION Labs Inc is voluntarily recalling all of the Influend cough and cold products sold on or after May 30, 2008.
ION Labs Inc is recalling the listed products because the products were not tested in conformance with the specifications of the laboratory. Therefore, the possibility exists that the products may be super potent. Possible complications may include tachycardia, palpitations, arrhythmias, cardiovascular collapse with hypotension, headaches, dizziness, anxiety, restlessness, and nervousness.
The following products were distributed and sold directly to consumers in the Madison/Huntsville, Ala, area:
- Influend Cold and Cough, 24 Tablets, product code/lot number 800074;
- Influend Severe Cold & Flu, 24 Tablets, product code/lot number 800075;
- Influend JR Cold & Cough, 4-oz bottle, product code/lot number 800076; and
- Influend JR Severe Cold & Flu, 4-oz bottle, product code/lot number 800077.
Although no illnesses have been reported to date, ION Labs Inc has ceased distributing these products until further notice.
Customers who possess this product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.
ION Labs Inc
115th Avenue N
Clearwater, FL 33760
Any adverse events that may be related to using this product should be reported to the FDA's MedWatch Program:
- Phone: 1-800-FDA-1088;
- Fax: 1-800-FDA-0178;
- Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or
- Online: MedWatch Web site, www.fda.gov/medwatch.
Consumers with questions about the recall may contact ION Labs Customer Service at 1-877-990-4466 and ask for the Quality Director at extension 212. Hours of operation are Monday through Friday from 8 AM to 5 PM EDT.
圣路易斯(MD Consult)――ION Labs公司主动召回2008年5月30日及以后出售的所有治疗流感咳嗽和感冒的药品。
ION Labs公司召回上述产品主要是因为这些药品未符合实验室检验标准。因此，有可能效价过高，服用后可能导致心动过速、心悸、心律失常、低血压心血管性虚脱、头痛、眩晕、焦虑、烦躁不安、紧张等并发症。
下列产品直接被售往阿拉巴马州的麦迪逊/亨维尔地区：
n 流感和咳嗽，24片，产品编码/批号 800074；
n 严重流感，24片，产品编码/批号800075；
n JR流感和咳嗽，4盎司/瓶，产品编码/批号800076；
n 严重JR流感，4盎司/瓶，产品编码/批号800077。
尽管目前还没有病例报道，在另行通知之前，ION Labs公司已经停止发售这些药物。
已购买这些药物的消费者应立即停止使用，如有与服该药有关的任何问题出现均应与医生联系。请将上述药物退回到如下地址，将获全额退款。
ION Labs Inc
115th Avenue N
Clearwater, FL 33760
如发生与使用该产品相关的任何不良反应，应向FDA的MedWatch项目报告。
n 电话：1-800-FDA-1088；
n 传真：1-800-FDA-0178；
n 地址：MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787；
n 在线：MedWatch网站 www.fda.gov/medwatch
消费者如有疑问可拨打ION Labs公司客服电话1-877-990-4466 转212分机向质量总监咨询。服务时间为周一至周五，8:00-17:00。
