Drug recall D-0611-2021
Product
Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit)
Reason for recall
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.
Lots and codes
KP51207 exp 06/30/2022; KP52618 exp 10/31/2022
Recall details
- Recalling firm
- Novo Nordisk Inc, Plainsboro, NJ
- Quantity
- N/A
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 22, 2021
- Terminated
- December 9, 2022
Related products
- Fiasp – drug information
- NDC 0169-3205 Fiasp · Insulin Aspart 100 [iU]/mL · Novo Nordisk
- NDC 0169-3206 Fiasp · Insulin Aspart 100 [iU]/mL · Novo Nordisk
- NDC 0169-3201 Fiasp · Insulin Aspart 100 [iU]/mL · Novo Nordisk
- NDC 0169-3204 Fiasp · Insulin Aspart 100 [iU]/mL · Novo Nordisk