# FDA recall D-0623-2021

> **Novo Nordisk Inc** · Class I · drug recall initiated 2021-03-22.

## Product

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: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0623-2021
- **Recalling firm:** Novo Nordisk Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-03-22
- **Report date:** 2021-04-21
- **Termination date:** 2022-12-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0623-2021

## Citation

> AI Analytics. FDA recall D-0623-2021. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-0623-2021. Source: US FDA. Licensed CC0.

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