Drug recall D-0623-2021

Class I Terminated reported Apr 21, 2021

Product

Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)

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

JP54291, exp 06/20/2021

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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