Novo Nordisk Recalls Levemir Insulin Pens Due to Temperature Abuse
Novo Nordisk is recalling Levemir FlexTouch insulin pens stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a severity score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Novo Nordisk Inc. is recalling Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only. The recall is due to temperature abuse, where product samples were stored at temperatures below 32°F, which is not in accordance with storage requirements.
This temperature exposure could cause a lack of efficacy and damage to the cartridge and pen-injectors. The affected product is identified by lot number KP51933 with an expiration date of 07/31/2022. The product was distributed nationwide in the USA.
Consumers should stop using the affected Levemir FlexTouch pens and contact their healthcare provider or pharmacist for guidance on replacement or alternative treatment options. The recall is classified as FDA Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- LEVEMIR (INSULIN DETEMIR)
- Brand
- LEVEMIR
- 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)
- KP51933 exp 07/31/2022
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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