FDA Recall Insulin Diluting Medium For Novolog

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Insulin Diluting Medium For Novolog with NDC 0169-2001 was initiated on 03-22-2021 as a Class I recall due to 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. The latest recall number for this product is D-0615-2021 and the recall is currently terminated as of 12-09-2022 .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0615-202103-22-202104-21-2021Class INovoLog 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)Terminated
D-0616-202103-22-202104-21-2021Class INovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90Terminated

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.