FDA Recall D-0620-2021
Novo Nordisk Inc · Plainsboro, NJ
Class I — life-threatening Terminated 627 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
TRESIBA (insulin degludec 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 0169-2662-90
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.
Recall record
- Recall number
D-0620-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2021-03-22
- Classified by FDA Center
- 2021-06-10
- FDA published
- 2021-04-21
- Terminated
- 2022-12-09
- Recalling firm
- Novo Nordisk Inc
- Firm location
- Plainsboro, NJ
Drug identification
- Brand name(s)
- TRESIBA
- Generic name(s)
- INSULIN DEGLUDEC
- Manufacturer(s)
- Novo Nordisk
- NDC(s)
0169-2550, 0169-2660, 0169-2662- Route(s)
- SUBCUTANEOUS