Class II · Moderate risk
Myxredlin
CGMP Deviations
TRESIBA FlexTouch (Insulin Degludec)
Class I — High risk. Reasonable probability of serious harm or death.
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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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)
Affected NDCs
0169-2550-90
0169-2550-97
Compare with the code on your package — it is the most precise check available.
Drug: Insulin Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tresiba insulin degludec NDC 00169-2550 |
200 U/mL | Injection, Solution Subcutaneous |
Novo Nordisk | Rx |
- Recalling firm
- Novo Nordisk Inc
- NDC code
- 0169-2550-90
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0621-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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CGMP Deviations
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Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Other recalls by Novo Nordisk Inc
All 2021 recalls
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class I · High risk
Xultophy 100/3.6
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.
Class II · Moderate risk
ViCTOZA (liraglutide)
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.
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