Drug recall D-0613-2021

Class I Terminated reported Apr 21, 2021

Product

Fiasp (insulin aspart 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 0169-3201-90

Reason for recall

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.

Lots and codes

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

Recall details

Recalling firm
Novo Nordisk Inc, Plainsboro, NJ
Quantity
N/A
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 22, 2021
Terminated
December 9, 2022

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