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FDA classifies Novo Nordisk insulin pen recalls as Class I

June 11, 2021 By Brian Buntz

FDA-logo-newIn May, Novo Nordisk announced that it voluntarily recalled 1,468 product samples related to its Levemir, Tresiba, Fiasp, Novolog and Xultophy insulin lines.

The products were held at sub-freezing temperatures, prompting the FDA to recently classify the recalls as Class I. FDA uses the Class I designation for situations where there is “a reasonable probability” that a product could cause “serious adverse health consequences or death.” Using insulin from one of the recalled pens could lead to potentially dangerous hyper- or hypoglycemia.

The cold temperatures could interfere with the insulin’s efficacy or damage the cartridge and pen-injectors.

Novo Nordisk has stressed that the recall only covers product samples rather than products distributed to conventional or mail-order pharmacies.

FDA lists the specific impacted lot numbers on its website.

FDA also posted the initial Novo Nordisk recall announcement on its website.

Novo Nordisk also noted that it has communicated with physician offices who received samples from the affected lots and asked them to return the samples.

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Food & Drug Administration (FDA) Tagged With: FDA, Fiasp, https://www.drugdiscoverytrends.com/pharma50/novo-nordisk/, Levemir, Novo Nordisk, Novolog, recalls, Tresiba, Xultophy

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About Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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