FDAFDA · Food and drugs·Recall number D-0615-2021
NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)
Published April 21, 2021 · Recall initiated: March 22, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- INSULIN DILUTING MEDIUM FOR NOVOLOG
- Manufacturer
- Novo Nordisk Inc
- Distributor
- Nationwide in the USA
- Lot
- KS6BS11, Exp 11/30/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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