Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)

FDA recall notice · announced April 21, 2021 · Novo Nordisk

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide in the USA
Lot/code information: K1620A1 (Kit); KZFH714 (Pen) exp 05/31/2022; B2020A (Kit); JZFF482 (Pen) exp 11/30/2021; I2320A (Kit); KZFH714 (Pen) exp 05/31/2022; H1020A (Kit); KZFH714 (Pen) exp 05/31/2022; J0520A(Kit); KZFH714 (Pen) exp 05/31/2022
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 (D-0615-2021)
- OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, D (D-0617-2021)
- ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060 (D-0622-2021)
- TRESIBA (insulin degludec 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 0169-2662-90 (D-0620-2021)
- Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169 (D-0612-2021)
- Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: N (D-0623-2021)
- 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., Plai (D-0614-2021)
- Fiasp (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 0169-3201-90 (D-0613-2021)
- 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 Nord (D-0611-2021)
- TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plai (D-0619-2021)
- NovoLog (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 0169-7501-90 (D-0616-2021)
- 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, Plain (D-0621-2021)
- Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, (D-0618-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.