Drug 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
D-0389-2021
Product summary
- Event
- Event 87809
- Status
- Terminated
- Classification
- Class II
- Quantity
- 709 cases
- Official record key
drug-enforcement:D-0389-2021
Official wording
Reason: Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Code information: Lot #20SU03019, Exp 6/2022
Distribution pattern: USA Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Mix-up