FDA Recall D-0623-2021
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
Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)
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-0623-2021- 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)
- XULTOPHY 100/3.6
- Generic name(s)
- INSULIN DEGLUDEC AND LIRAGLUTIDE
- Manufacturer(s)
- Novo Nordisk
- NDC(s)
0169-2911- Route(s)
- SUBCUTANEOUS