诺和诺德公司召回: 回波和笔胰岛素输送装置

Novo Nordisk is recalling certain Novopen Echo Insulin Delivery Devices due to potential health risks, including high blood sugar levels.

Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents.

NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar.

Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.

The warning signs of high blood sugar (也称为高血糖) typically appear gradually and might include flushed, dry skin; feeling sleepy or tired; 口干, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).

Patients using an affected pen may want to check their blood sugar level more frequently until receiving a new cartridge holder. Patients should contact their health care provider if they believe they’re experiencing hyperglycemia.

The affected batches were distributed between 8/1/2016 – 6/22/2017 对分销商, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide.

Novo Nordisk is notifying distributors, 药房, healthcare professionals and patients by mail and is arranging for product replacement. Replacement cartridge holders will be provided for NovoPen Echo® from the following batches:

产品图片

Novo Nordisk Recalls Insulin Pen

诺和诺德公司召回

美国. batch numbers:

EVG1221
EVG1226
FVG7149
FVG7458
FVG8134
FVG8135

If patients are in possession of a NovoPen Echo® device with a batch number which is not mentioned above, there is no reason for concern and they can be confident that the pen will work as intended.

Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date.

Novo Nordisk has corrected this problem and has determined no other component of the pen is affected.

Novo Nordisk is committed to delivering high-quality products and sincerely apologizes to patients and health care professionals. We are working closely with the U.S Food and Drug Administration to ensure patient safety and further minimize disruption.

在美国, people with diabetes using a NovoPen Echo® from one of the affected batches listed above are instructed to call Novo Nordisk at 1-855-419-8827 之间 8 am and 6 pm EDT to get a replacement cartridge holder. For questions specific to the recall, please call 1-855-419-8827. If you have any other general questions or concerns, please contact Novo Nordisk Customer Care at 1-800-727-6500, 星期一至星期五, 8:30 我 — — 6 pm EDT.

不良反应或与使用本产品遇到的质量问题可能向 FDA 报告 ’ s MedWatch Adverse Event Reporting program online, 通过普通邮件或传真.

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