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Recall Observatory FDA recall evidence

Drug product

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)

D-0621-2021

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-0621-2021

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: KP52829 exp 07/31/2022; JP54181 exp 09/30/2021; KP51059 exp 11/30/2021; KP51865 exp 11/30/2021; KP54179 exp 11/30/2022; JP52179 exp 08/16/2021

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.