FDA recall D-0623-2021

Novo Nordisk Inc · Class I · drug

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.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2021-03-22
Report date
2021-04-21
Termination date
2022-12-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2021