Drug recall D-0389-2021

Class II Terminated reported May 26, 2021

Product

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

Reason for recall

Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.

Lots and codes

Lot #20SU03019, Exp 6/2022

Recall details

Recalling firm
Fresenius Medical Care, North America, Ogden, UT
Quantity
709 cases
Distribution
USA Nationwide
Type
Voluntary: Firm initiated
Recall initiated
April 14, 2021
Terminated
April 5, 2022

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