Medicine recalls
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| The United States: Novo Nordisk issues voluntary nationwide recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® product samples due to improper storage temperature conditions |
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The US Food and Drug Administration (FDA) announces that Novo Nordisk is voluntarily recalling 1,468 product samples of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts product samples and does not impact product that has been broadly distributed to pharmacies or mail-order services.
These products are used to lower blood glucose levels in people with diabetes and are packaged in cartons with either a vial, pen-injector (FlexPen® or FlexTouch®) or a cartridge (PenFill®). The affected product samples include: Fiasp® FlexTouch®, Fiasp® PenFill®, Fiasp® Vial, Levemir® FlexTouch®, NovoLog® FlexPen®, NovoLog® Vial, Tresiba® U100, FlexTouch®, Tresiba® U200, FlexTouch®, Tresiba® Vial, Xultophy® Pen. For details of the affected lots, please refer to the website in FDA.
If product samples are exposed to temperatures below 32°F, it could cause a lack of efficacy and damage to the cartridge and pen-injectors. If product from an improperly stored vial, cartridge or pen-injector is used, there is a risk that you might not receive the right amount of medicine as intended which may lead to hyperglycemia or hypoglycemia resulting in adverse health consequences ranging from limited to life-threatening. Novo Nordisk has not received any reports of serious adverse events or injuries related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novo-nordisk-issues-voluntary-nationwide-recall-levemirr-tresibar-fiaspr-novologr-and-xultophyr
In Hong Kong, Levemir FlexPen Inj 100U/ml (HK-53538), Levemir FlexPen Solution For Injection In Pre-filled Pen 100U/ml (HK-65011), Tresiba FlexTouch Solution For Injection In Pre-filled Pen 200U/ml (HK-62699), Tresiba FlexTouch Solution For Injection In Pre-filled Pen 100U/ml (HK-62700) and Xultophy Solution For Injection In A Pre-filled Pen 100 Units/ml+3.6mg/ml (HK-65897) are pharmaceutical products registered by Novo Nordisk Hong Kong Ltd (Novo Nordisk). There is no registered pharmaceutical product with brand name Fiasp and Novolog.
As confirmed with Novo Nordisk, the product samples mentioned in the above FDA’s announcement have not been imported into Hong Kong.
Ends/Tuesday, May 11, 2021
Issued at HKT 16:00
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