Class III · Low risk
Magnesium Chloride
Subpotent drug
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Temperature Abuse: Product exposed to temperature outside specified limits.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) Rx only, Fresenius Medical Care NA Waltham, MA 02451
Affected NDCs
49230-0209-23
49230-0209-30
49230-0209-50
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Delflex Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride NDC 49230-0209 |
DEXTROSE MONOHYDRATE 2.5 g/100mL; SODIUM CHLORIDE 538 mg/100mL; SODIUM LACTATE 448 mg/100mL; CALCIUM CHLORIDE 18.4 mg/100mL; MAGNESIUM CHLORIDE 5.08 mg/100mL | Solution Intraperitoneal |
Fresenius Medical Care Renal Therapies Group, LLC | Rx |
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- NDC code
- 49230-0209-23
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0605-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Other recalls by Fresenius Medical Care Holdings, Inc.
All 2021 recalls
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW…
This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
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