# FDA recall D-0389-2021

> **Fresenius Medical Care, North America** · Class II · drug recall initiated 2021-04-14.

## Product

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451

## Reason for recall

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0389-2021
- **Recalling firm:** Fresenius Medical Care, North America
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-14
- **Report date:** 2021-05-26
- **Termination date:** 2022-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ogden, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2021

## Citation

> AI Analytics. FDA recall D-0389-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/D-0389-2021. Source: US FDA. Licensed CC0.

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