Recalls / Class I
Class ID-0614-2021
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
Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit)
- Brand name
- Levemir
- Generic name
- Insulin Detemir
- Active ingredient
- Insulin Detemir
- Route
- Subcutaneous
- NDCs
- 0169-3687, 0169-6438, 0169-6432
- FDA application
- BLA021536
- Affected lot / code info
- KP51933 exp 07/31/2022
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-0614-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.