Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
DELFLEX Peritoneal Dialysis Solution with 1.5% 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 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
Affected NDC
49230-0188-50
Compare with the code on your package — it is the most precise check available.
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 49230-0188 |
DEXTROSE MONOHYDRATE 1.5 g/100mL; SODIUM CHLORIDE 567 mg/100mL; SODIUM LACTATE 392 mg/100mL; CALCIUM CHLORIDE 25.7 mg/100mL; MAGNESIUM CHLORIDE 15.2 mg/100mL | Solution Intraperitoneal |
Fresenius Medical Care Renal Therapies Group, LLC | Rx |
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- NDC code
- 49230-0188-50
- Origin
- MA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0604-2021 · 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 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
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.
Other temperature excursion recalls from 2021
All temperature excursion recalls
Class I · High risk
Enoxaparin Sodium Injection
Temperature Abuse; temperature excursion during shipping
Class I · High risk
Atovaquone Oral Suspension
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Temperature Abuse: Product exposed to temperature outside specified limits.
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