Fiasp Injection, Solution
FDA Recall NDC 0169-3206
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Fiasp (NDC 0169-3206). 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
Fiasp (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 0169-3201-90
Batch or Lot Expiration Information
Lot# KS6BX63 exp 10/31/2022; KS6AK76 exp 05/31/2022; KS6BR92 exp 09/30/2022
Affected Packages Involved in this Recall
0169-3201-11Product
0169-3201-90Product
0169-3204-15Product
0169-3204-90Product
0169-3204-97Product
0169-3205-11Product
0169-3205-15Product
0169-3205-91Product
0169-3205-95Product
0169-3206-11Product
0169-3206-15Product
0169-3206-91Product
0169-3206-95Product
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
Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit)
Batch or Lot Expiration Information
Lot# KP51207 exp 06/30/2022; KP52618 exp 10/31/2022
Affected Packages Involved in this Recall
0169-3201-11Product
0169-3201-90Product
0169-3204-15Product
0169-3204-90Product
0169-3204-97Product
0169-3205-11Product
0169-3205-15Product
0169-3205-91Product
0169-3205-95Product
0169-3206-11Product
0169-3206-15Product
0169-3206-91Product
0169-3206-95Product
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
Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91
Batch or Lot Expiration Information
Lot# KS6BF84, Exp 06/30/2022
Affected Packages Involved in this Recall
0169-3201-11Product
0169-3201-90Product
0169-3204-15Product
0169-3204-90Product
0169-3204-97Product
0169-3205-11Product
0169-3205-15Product
0169-3205-91Product
0169-3205-95Product
0169-3206-11Product
0169-3206-15Product
0169-3206-91Product
0169-3206-95Product
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.
