Drug recall D-0620-2021
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.
Lots and codes
JZFE233 exp 11/30/2021
Recall details
- Recalling firm
- Novo Nordisk Inc, Plainsboro, NJ
- Quantity
- N/A
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 22, 2021
- Terminated
- December 9, 2022
Related products
- Tresiba – drug information
- NDC 0169-2660 Tresiba · Insulin Degludec 100 U/mL · Novo Nordisk
- NDC 0169-2550 Tresiba · Insulin Degludec 200 U/mL · Novo Nordisk
- NDC 0169-2662 Tresiba · Insulin Degludec 100 U/mL · Novo Nordisk