The Recall Desk
ModerateFDA (Devices)·Z-0206-2018·Announced 2017-12-13

Novo Nordisk Recalls Dial-A-Dose Insulin Pen Cartridge Holders

Novo Nordisk is recalling specific batches of Dial-A-Dose insulin pen cartridge holders because they may crack or break when exposed to certain cleaning agents.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to physical cracking or breaking upon exposure to specific chemicals, with no reported injuries or illnesses. This aligns with the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Novo Nordisk Inc is recalling 16,557 units of Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders. The affected product is the NovoPen Echo, a reusable pen injector used by patients with diabetes for the self-injection of insulin. The device is designed to work with Penfill 3 mL cartridges of NovoLog (insulin aspart) and single-use detachable pen needles.

The recall was initiated because a small number of batches may crack or break if exposed to certain chemicals, such as specific cleaning agents. The affected U.S. batch numbers are EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135. The product was distributed nationwide.

Consumers should check the batch number on their cartridge holders to see if they are affected. If the batch number matches one of the listed codes, users should stop using the product and contact Novo Nordisk for instructions on how to proceed.

The recalled product

Product
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¿,
Manufacturer
Novo Nordisk Inc
Affected units
16,557

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • U.S. batch numbers: EVG1221
  • EVG1226
  • FVG7149
  • FVG7458
  • FVG8134 & FVG8135

Distribution

Distributed nationwide across the United States.