Novo Nordisk Inc: Drug Recall

Recall Details

Recall Number

D-0621-2021

Classification

Class I

Product Type

Drug

Recalling Firm

Novo Nordisk Inc

Status

Terminated

Date Initiated

03/22/2021

Location

Plainsboro, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

N/A

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.

Product Description

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)

Distribution Pattern

Nationwide in the USA

Other Recalls by Novo Nordisk Inc

• Class II: Risk 12/19/2025
  Presence of Particulate Matter: Hair was found in a prefilled syringe
• Class II: Risk 12/19/2025
  Presence of Particulate Matter: Hair was found in a prefilled syringe
• Class II: Risk 03/22/2021
  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.
• Class I: Dangerous 03/22/2021
  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.
• Class II: Risk 03/22/2021
  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.

View all recalls by Novo Nordisk Inc →