D-0612-2021 Class I Terminated
FDA drug recall D-0612-2021 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 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
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
KS6BF84, Exp 06/30/2022
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0612-2021
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026