The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0613-2021·Announced 2021-04-21

Novo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse

Novo Nordisk is recalling Fiasp (insulin aspart injection) 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 minimum severity score of 4 per the rubric, as Class I recalls involve a reasonable probability of serious adverse health consequences or death.

Plain-English summary

Novo Nordisk Inc is recalling Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. The affected products are identified by lot codes KS6BX63 (exp 10/31/2022), KS6AK76 (exp 05/31/2022), and KS6BR92 (exp 09/30/2022). The recall is due to temperature abuse, as the product samples were stored at temperatures below 32°F, which is not in accordance with storage requirements.

This temperature deviation could cause a lack of efficacy and damage to the cartridge and pen-injectors. The affected products were distributed nationwide in the USA. The source text does not specify the number of units recalled or report any illnesses or injuries associated with this recall.

Consumers and healthcare providers should check their inventory for the specific lot codes and expiration dates listed above. If these products are found, they should be stopped from use and returned to the distributor or manufacturer in accordance with standard recall procedures.

The recalled product

Product
FIASP (INSULIN ASPART INJECTION)
Brand
FIASP
Manufacturer
Novo Nordisk Inc
Category
Drug — Insulin
Hazard

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 (3)

  • KS6BX63 exp 10/31/2022
  • KS6AK76 exp 05/31/2022
  • KS6BR92 exp 09/30/2022

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.

See all 13 products in this recall →

Related recalls

Same brand · FIASP

Same manufacturer · Novo Nordisk Inc

See all →

Same hazard · lack of efficacy

See all →

Similar recalls