Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.
What this means for you
Illness, injury, or structural failure has been reported. 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, as it poses a reasonable probability of serious adverse health consequences or death due to lack of efficacy.
Plain-English summary
Novo Nordisk Inc is recalling specific lots of TRESIBA (insulin degludec) 200 units/mL (U-200) 3 mL Prefilled Pens. The recall is due to temperature abuse, where product samples were stored at temperatures below 32°F, which does not meet storage requirements.
This improper storage could cause a lack of efficacy in the insulin and damage to the cartridge and pen-injectors. The affected products are distributed nationwide in the USA.
Consumers should check their TRESIBA pens against the specific lot codes and expiration dates listed in the official recall notice. If a pen matches the recalled lots, it should not be used. Patients should contact their healthcare provider or Novo Nordisk for replacement or 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 (6)
- KP52829 exp 07/31/2022
- JP54181 exp 09/30/2021
- KP51059 exp 11/30/2021
- KP51865 exp 11/30/2021
- KP54179 exp 11/30/2022
- JP52179 exp 08/16/2021
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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