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
Reported: May 26, 2021 Initiated: April 14, 2021 #D-0389-2021
Product Description
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.
Details
- Recalling Firm
- Fresenius Medical Care, North America
- Units Affected
- 709 cases
- Distribution
- USA Nationwide
- Location
- Ogden, UT
Frequently Asked Questions
What product 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. Recalled by Fresenius Medical Care, North America. Units affected: 709 cases.
Why was this product recalled? ▼
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 26, 2021. Severity: Moderate. Recall number: D-0389-2021.
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