FDAFDA · Food and drugs·Recall number D-0389-2021
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
Published May 26, 2021 · Recall initiated: April 14, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fresenius Medical Care, North America
- Distributor
- USA Nationwide
- Lot
- Lot #20SU03019, Exp 6/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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