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Novo Nordisk Recalls Popular Insulin Injector Nationwide Due to Defect

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Pharmaceutical company Novo Nordisk has voluntarily recalled certain insulin cartridge holders used in NovoPen Echo products. Novo Nordisk determined that the affected holders may become damaged or break if exposed to certain chemicals, including cleaning products. Damage to the holder may result in the NovoPen Echo not delivering enough insulin to the user, which could potentially lead to high blood sugar.

Warning signs of high blood sugar (or hyperglycemia) typically appear over time and can include: flushed, dry skin; feeling sleepy or tired; dry mouth, breath taking on a fruity scent; urinating more often, feeling thirsty; loss of appetite, feeling or being sick. Novo Nordisk is advising users with an affected device to check their blood sugar levels more frequently until they receive a replacement holder.

The affected batches of holders were sent to various distributors, sales representatives, and replacement programs for nationwide distribution between August 1, 2016 and June 22, 2017.

Novo Nordisk is offering to replace any unit from the following US batch numbers, which can be found on the NovoPen Echo near the end of the device:

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Where to find the batch number (PRNewsfoto/Novo Nordisk)

  • EVG1221
  • EVG1226
  • FVG7149
  • FVG7458
  • FVG8134
  • FVG8135

Novo Nordisk began to investigate NovoPen Echo products following numerous complaints of damaged cartridge holders and reports of adverse effects from users. Novo Nordisk has reportedly corrected the problem that lead to the recall, and determined that no other part of the NovoPen Echo is affected.

Users of a NovoPen Echo from one of the affected batch numbers or users with any questions or concerns regarding the recall should contact Novo Nordisk at 1-855-419-8827 (Monday-Friday 8 a.m. to 6 p.m. Eastern Daylight Time). Users should contact their doctor or healthcare provider if they believe they have, or are experiencing, symptoms caused by high blood sugar (or hyperglycemia).

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online: fda.gov/medwatch/report.htm
  • Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor
  • Call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.