Delflex Peritoneal Dialysis Solution with 1 — Class II drug recall D-0389-2021
Terminated recall by Fresenius Medical Care, North America, reported 2021-05-26, distributed nationwide. Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
| Recall number | D-0389-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care, North America, Ogden, UT, United States |
| Recall initiated | 2021-04-14 |
| Classified | 2021-05-19 |
| Reported by FDA | 2021-05-26 |
| Terminated | 2022-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 709 cases |
| Reason classes | labeling |
| NDC | 49230-0206-60 |
| Lot numbers | 20SU03019 |
| Expiration dates | 2022-06 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0389-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.