Novo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse
Novo Nordisk is recalling TRESIBA (insulin degludec) samples stored below 32°F, which 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 severity score of at least 4 per the rubric.
Plain-English summary
Novo Nordisk Inc is recalling TRESIBA (insulin degludec injection) 100 units/mL (U-100) samples. The affected product is a one 10 mL multi-dose vial, marked as "Sample. Not for Resale, Rx only." The specific lot code is JZFE233 with an expiration date of 11/30/2021.
The recall was initiated because the product samples were stored at temperatures below 32°F, which does not meet storage requirements. This temperature abuse could cause a lack of efficacy and damage to the cartridge and pen-injectors.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the affected TRESIBA samples and contact their healthcare provider or Novo Nordisk for further instructions.
The recalled product
- Product
- TRESIBA (INSULIN DEGLUDEC)
- Brand
- TRESIBA
- Manufacturer
- Novo Nordisk Inc
- Category
- Drug — Insulin
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 (1)
- JZFE233 exp 11/30/2021
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.
See all 13 products in this recall →Related recalls
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