FDA recall D-0620-2021

Novo Nordisk Inc · Class I · drug

Product

TRESIBA (insulin degludec 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 0169-2662-90

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

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-0620-2021