D-0616-2021 Class I Terminated

Recalled by Novo Nordisk Inc — Plainsboro, NJ

Recall Details

Product Type
Drugs
Report Date
April 21, 2021
Initiation Date
March 22, 2021
Termination Date
December 9, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

NovoLog (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 0169-7501-90

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.

Distribution Pattern

Nationwide in the USA

Code Information

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