Novo Nordisk Recalls Norditropin Pens Due to Delivery System Defect
Novo Nordisk is recalling 723 Norditropin FlexPro pens due to a potential assembly fault that may cause the pen to block during the air shot step.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (injection device malfunction) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Novo Nordisk Inc. is recalling 723 units of Norditropin (somatropin) FlexPro Prefilled Pens, NDC 0169-7703-21, Lot Number FC70222. The recall is due to a defective delivery system characterized by a low frequency assembly fault. This fault may result in the pen blocking during the "air shot" step of the injection process.
The affected pens were distributed nationwide. Norditropin is a prescription-only medication containing somatropin (rDNA origin) used for subcutaneous injection. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should stop using the affected pens and contact their healthcare provider or Novo Nordisk for further instructions. Consumers should check their medication packaging for the specific lot number and NDC code to determine if their product is affected.
The recalled product
- Product
- NORDITROPIN (SOMATROPIN)
- Brand
- NORDITROPIN
- Manufacturer
- Novo Nordisk Inc
- Category
- Drug — Prescription Injection
- Affected units
- 723
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)
- Lot Number FC70222
Distribution
Distributed nationwide across the United States.
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