Novo Nordisk Inc recalls Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pe…

Recall date

July 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0206-2018

FDA classification

Class II

Brand / firm

Novo Nordisk Inc

Sold / distributed

Nationwide distribution

Why it was recalled

A small number of batches may crack or break if exposed to certain chemicals, like certain cleaning agents.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.