US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 14, 2021 (5 years ago)

Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case…

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.

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

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

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.