Skip to content
Recall Observatory FDA recall evidence

Drug product

TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90

D-0620-2021

March 22, 2021

Class I

Product summary

Firm
Novo Nordisk Inc
Event
Event 87537
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0620-2021

Official wording

Reason: Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.

Code information: JZFE233 exp 11/30/2021

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.