FDA Drug recall D-0621-2021
TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 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) 200 units/mL (U-200), 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-0621-2021 |
| 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) 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, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (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 | KP52829 exp 07/31/2022; JP54181 exp 09/30/2021; KP51059 exp 11/30/2021; KP51865 exp 11/30/2021; KP54179 exp 11/30/2022; JP52179 exp 08/16/2021 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0621-2021%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.