Fresenius Medical Care, North America: Drug Recall
Recall #D-0389-2021 · 04/14/2021
Class II: Risk
Recall Details
- Recall Number
- D-0389-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Fresenius Medical Care, North America
- Status
- Terminated
- Date Initiated
- 04/14/2021
- Location
- Ogden, UT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 709 cases
Reason for Recall
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
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
Distribution Pattern
USA Nationwide
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.