D-0611-2021 Class I Terminated
FDA drug recall D-0611-2021 was initiated by Novo Nordisk Inc on Mar 22, 2021 and is designated Class I. 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… The recall status is terminated (terminated Dec 9, 2022).
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 21, 2021
- Initiation Date
- Mar 22, 2021
- Termination Date
- Dec 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
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)
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.
Distribution Pattern
Nationwide in the USA
Code Information
KP51207 exp 06/30/2022; KP52618 exp 10/31/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0611-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026