Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Labeling: Missing Label
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
49230-0206-60
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 49230-0206 |
DEXTROSE MONOHYDRATE 1.5 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, North America
- NDC code
- 49230-206-60
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0389-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other labeling / mix-up recalls from 2021
All labeling / mix-up recalls
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class II · Moderate risk
Moxifloxacin
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets
Product Mix-up
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