Recalls / Class I
Class ID-0621-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)
- Brand name
- Tresiba
- Generic name
- Insulin Degludec
- Active ingredient
- Insulin Degludec
- Route
- Subcutaneous
- NDCs
- 0169-2550, 0169-2660, 0169-2662
- FDA application
- BLA203314
- Affected lot / code info
- KP52829 exp 07/31/2022; JP54181 exp 09/30/2021; KP51059 exp 11/30/2021; KP51865 exp 11/30/2021; KP54179 exp 11/30/2022; JP52179 exp 08/16/2021
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-0621-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.