CLASS III Drug recall · Reported 16 Jun 2021 · FDA Enforcement Report
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalled
Fresenius Medical Care Holdings is recalling Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, distributed nationwide in the US. The recall was initiated on 28 Apr 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0610-2021
- FDA event ID
- 87907
- Recalling firm
- Fresenius Medical Care Holdings, Waltham, MA
- Brand
- Delflex
- Manufacturer
- Fresenius Medical Care Renal Therapies Group, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Apr 2021
- FDA classified
- 9 Jun 2021
- Reported
- 16 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 28 Apr 2021 | Recall initiated by company | |
| 9 Jun 2021 | Classified by FDA | +42 days |
| 16 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Temperature Abuse: Product exposed to temperature outside specified limits.
Which lots are affected?
Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 87907This product is part of a recall event; the main page for the event is Sodium Chloride recalled by Fresenius Medical Care.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sodium Chloride recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delfelx Peritoneal Dialysis Solution with 4.25% Dextrose recalled | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 4.25% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 2.5 % Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 2.5% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalledDelflex | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide | |
| CLASS III | Delflex Peritoneal Dialysis Solution with 1.5% Dextrose recalled | Fresenius Medical Care Holdings | Temperature Abuse | Nationwide |
More recalls from Fresenius Medical Care Holdings
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5008X Blood Tubing Set recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | Nationwide |
| Device | CLASS II | Bicarby" Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Packaging Defects | Nationwide |
| Device | CLASS II | Bicarby Dialysate recalled by Fresenius Medical Care | Fresenius Medical Care Holdings | Other | TX |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
| Drug | CLASS II | Delflex, Dextrose Peritoneal Dialysis Solution recalled | Fresenius Medical Care Holdings | Sterility | Nationwide |
Other Dextrose recalls
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Dextrose Injection recalled by B Braun MedicalDextrose | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |
| Drug | CLASS II | 5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose | Fresenius Kabi USA | Sterility | Nationwide |