FDA-Drug2021-05-26Class II
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
Fresenius Medical Care, North America
Hazard
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Sold states
USA Nationwide
Affected count
709 cases
Manufactured in
475 W 13th St, N/A, Ogden, UT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2021Don't want to check this manually?
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