FDA Drug recall D-0619-2021
TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S…
- FDA Drug
- Class I
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class I recall of TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S… by Novo Nordisk, citing 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 t….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0619-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novo Nordisk |
| Distribution | US |
Product
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., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)
Reason
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.
Identifiers
| ndc | 0169-2660-15 |
|---|---|
| ndc | 0169-2660-90 |
| ndc | 0169-2660-97 |
| ndc | 0169-2550-13 |
| ndc | 0169-2550-90 |
| ndc | 0169-2550-97 |
| ndc | 0169-2662-11 |
| ndc | 0169-2662-90 |
| code_info | JP52771 exp 09/30/2021; JP53136 exp 06/30/2021; KP50575 exp 01/31/2022; KP50976 exp 01/31/2022; KP51813 exp 04/3…JP52771 exp 09/30/2021; JP53136 exp 06/30/2021; KP50575 exp 01/31/2022; KP50976 exp 01/31/2022; KP51813 exp 04/30/2022; KP52035 exp 04/30/2022; KP52117 exp 04/30/2022; KP52440 exp 06/30/2022; KP52461 exp 04/30/2022; KP52616 exp 06/30/2022; JP52361 exp 08/01/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Novo Nordisk
- Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark,…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark, P…
FDA Drug · Class II · 2026-01-07 · Novo Nordisk - Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample
FDA Drug · Class I · 2021-04-21 · Novo Nordisk - Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Ma…
FDA Drug · Class I · 2021-04-21 · Novo Nordisk
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.