PillDextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride
Brands: Delflex · Calcium Chloride + Dextrose Monohydrate + Magnesium Chloride + Sodium Chloride + Sodium Lactate
3 active makers
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Medicaid dispensing volume
No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.
Who makes it3 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | unknown | 24 | SUPPLYING |
| Fresenius Medical Care de Mexico, S.A. de C.V. | unknown | 9 | SUPPLYING |
| Fresenius Medical Care North America | unknown | 4 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Mar 10, 2026RESOLVEDShortage resolved: Peritoneal Dialysis Solution (Fresenius Medical Care North America)
Peritoneal Dialysis Solution — reported in shortage by Fresenius Medical Care North America. Therapeutic category: Renal.
- Mar 10, 2026SHORTAGEDrug shortage: Peritoneal Dialysis Solution (Fresenius Medical Care North America)
Peritoneal Dialysis Solution — reported in shortage by Fresenius Medical Care North America. Therapeutic category: Renal.
- Jun 18, 2024RECALLRecall (Class II): DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange S…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide
- Dec 28, 2023RECALLRecall (Class II): DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, packaged in 6000mL bags, Rx only, Fresenius Me…
Lack of Sterility Assurance — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 28, 2021RECALLRecall (Class III): DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set…
Temperature Abuse: Product exposed to temperature outside specified limits. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 28, 2021RECALLRecall (Class III): DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 4…
Temperature Abuse: Product exposed to temperature outside specified limits. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 28, 2021RECALLRecall (Class III): DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (N…
Temperature Abuse: Product exposed to temperature outside specified limits. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 28, 2021RECALLRecall (Class III): DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange set…
Temperature Abuse: Product exposed to temperature outside specified limits. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 28, 2021RECALLRecall (Class III): DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe Exchange se…
Temperature Abuse: Product exposed to temperature outside specified limits. — Recalling firm: Fresenius Medical Care Holdings, Inc. — Nationwide within the United States
- Apr 14, 2021RECALLRecall (Class II): Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only…
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box. — Recalling firm: Fresenius Medical Care, North America — USA Nationwide
- Dec 20, 2017RECALLRecall (Class II): DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2…
Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. — Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC — Product was distributed throughout the United States to patients and clinics.