Novo Nordisk Inc: Drug Recall

Recall #D-0615-2021 · 03/22/2021

Class I: Dangerous

Recall Details

Recall Number: D-0615-2021
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

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)

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 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 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 →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.