Drug product
ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)
D-0622-2021
Product summary
- Firm
- Novo Nordisk Inc
- Event
- Event 87537
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0622-2021
Official wording
Reason: 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.
Code information: I2419A (Kit); JS68K86 (Pen) exp 05/31/2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
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.