FDA Drug recall D-0617-2021
OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample
- FDA Drug
- Class II
- terminated
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample 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-0617-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-22 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novo Nordisk |
| Distribution | US |
Product
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, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (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
| code_info | KP50867, exp 10/31/2022, KP53021, exp 04/30/2023, KP52338, exp 02/28/2023, JP54354, exp 08/31/2022, KP50676, e…KP50867, exp 10/31/2022, KP53021, exp 04/30/2023, KP52338, exp 02/28/2023, JP54354, exp 08/31/2022, KP50676, exp 10/31/2022, KP51434, exp 11/30/2022, KP51491, exp 11/30/2022, KP51781, exp 01/31/2023, KP52249, exp 01/31/2023, KP52270, exp 01/31/2023, KP52722, exp 01/31/2023, KP52973, exp 01/31/2023, KP53031, exp 01/31/2023, KP53221, exp 12.04.2023, KP53369, exp 01/31/2023 |
|---|
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-0617-2021%22
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