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Recall Observatory FDA recall evidence

Drug product

ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)

D-0622-2021

March 22, 2021

Class II

Product summary

Firm
Novo Nordisk Inc
Event
Event 87537
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0622-2021

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: I2419A (Kit); JS68K86 (Pen) exp 05/31/2021

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.