Recalls / Class II
Class IID-0622-2021
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)
- Brand name
- Victoza
- Generic name
- Liraglutide
- Active ingredient
- Liraglutide
- Route
- Subcutaneous
- NDC
- 0169-4060
- FDA application
- NDA022341
- Affected lot / code info
- I2419A (Kit); JS68K86 (Pen) exp 05/31/2021
Why it was recalled
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.
Recalling firm
- Firm
- Novo Nordisk Inc
- Manufacturer
- Novo Nordisk
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 800 Scudders Mill Rd, N/A, Plainsboro, New Jersey 08536-1606
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-22
- FDA classified
- 2021-06-10
- Posted by FDA
- 2021-04-21
- Terminated
- 2022-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0622-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.