In 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 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.