D-0389-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 26, 2021
- Initiation Date
- April 14, 2021
- Termination Date
- April 5, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 709 cases
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.
Distribution Pattern
USA Nationwide
Code Information
Lot #20SU03019, Exp 6/2022