Novo Nordisk Recalls Xultophy 100/3.6 Due to Temperature Abuse
Novo Nordisk is recalling Xultophy 100/3.6 samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Novo Nordisk Inc is recalling Xultophy 100/3.6 (insulin degludec and liraglutide injection) samples. The affected product is the 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, identified by lot code JP54291 and expiration date 06/20/2021. The recall is due to temperature abuse, as the product samples were stored at temperatures below 32°F, which does not meet storage requirements.
This temperature exposure could cause a lack of efficacy and damage to the cartridge and pen-injectors. The product is distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or Novo Nordisk for further instructions.
The recalled product
- Product
- XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE)
- Brand
- XULTOPHY 100/3.6
- Manufacturer
- Novo Nordisk Inc
- Category
- Drug — Insulin / Diabetes
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- JP54291
- exp 06/20/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Novo Nordisk Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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