The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0616-2021·Announced 2021-04-21

Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

Novo Nordisk Inc is recalling samples of Insulin Diluting Medium for NovoLog because storage below 32°F may cause lack of efficacy and damage to cartridges 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 FDA classified this recall as Class I, which indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death. The rubric states that FDA Class I recalls must be scored at least 4.

Plain-English summary

Novo Nordisk Inc has initiated a voluntary recall of product samples identified as "Insulin Diluting Medium for NovoLog (Water Injection)". The affected items are NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), specifically one 10 mL multi-dose vials marked as samples and not for resale. The products were manufactured by Novo Nordisk A/S in Bagsvaerd, Denmark.

The recall is necessary because the product samples were stored at temperatures below 32°F, which violates required storage conditions. This temperature abuse could result in a lack of efficacy of the insulin diluting medium and cause physical damage to the cartridge and pen-injectors.

The recalled products are distributed nationwide within the USA. Affected lot numbers include JZFC826 with an expiration date of 06/30/2021, and KZFM305 with an expiration date of 08/31/2022. The FDA has classified this recall as Class I.

Consumers who possess these specific product samples should check their storage conditions and lot numbers. If the product was stored below freezing or shows signs of damage, it should not be used due to potential efficacy issues.

The recalled product

Product
INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
Brand
INSULIN DILUTING MEDIUM FOR NOVOLOG
Manufacturer
Novo Nordisk Inc
Category
Drug — Insulin Diluting Medium Samples
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 (2)

  • JZFC826 exp 06/30/2021
  • KZFM305 exp 08/31/2022

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.

See all 13 products in this recall →

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