FDA recall D-0615-2021

Product

NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (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-0615-2021