Novolog Injection, Solution
FDA Recall NDC 0169-2100
Latest: Class I · Status: Terminated · Initiated Mar 22, 2021 · 2 enforcement reports
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Novolog (NDC 0169-2100). A significant event, classified as Class I, was initiated on Mar 22, 2021 by Novo Nordisk. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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.
Mar 22, 2021
Apr 21, 2021
N/A
Recall Profile & Regulatory Data
Event ID
87537
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Novo Nordisk Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 09, 2022
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)
Batch or Lot Expiration Information
Lot# KS6BS11, Exp 11/30/2021
Affected Packages Involved in this Recall
0169-7501-11Novolog
0169-7501-90Novolog
0169-3303-12Novolog
0169-3303-91Novolog
0169-3303-90Novolog
0169-6339-10Novolog
0169-6339-90Novolog
0169-6339-97Novolog
0169-6339-98Novolog
0169-6338-10Novolog
0169-6338-90Novolog
0169-6338-97Novolog
0169-2001-90Novolog
0169-2100-11Novolog
0169-2101-12Novolog
0169-2101-25Novolog
Class I Terminated
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.
Mar 22, 2021
Apr 21, 2021
N/A
Recall Profile & Regulatory Data
Event ID
87537
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Novo Nordisk Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Dec 09, 2022
Product Description
NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90
Batch or Lot Expiration Information
Lot# JZFC826 exp 06/30/2021; KZFM305 exp 08/31/2022
Affected Packages Involved in this Recall
0169-7501-11Novolog
0169-7501-90Novolog
0169-3303-12Novolog
0169-3303-91Novolog
0169-3303-90Novolog
0169-6339-10Novolog
0169-6339-90Novolog
0169-6339-97Novolog
0169-6339-98Novolog
0169-6338-10Novolog
0169-6338-90Novolog
0169-6338-97Novolog
0169-2001-90Novolog
0169-2100-11Novolog
0169-2101-12Novolog
0169-2101-25Novolog
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
