Drug recall D-0610-2021
Product
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium, packaged in a) 3000 mL bags (NDC 49230-206-30) and b) 5000mL bags, 2 packs (NDC 49230-206-50), Rx only, Fresenius Medical Care NA, Waltham, MA 02451
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Lots and codes
Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
- Quantity
- 285 cases
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 28, 2021
- Terminated
- September 17, 2021
Related products
- Delflex – drug information
- NDC 49230-209 Delflex · Sodium Chloride 538 mg/100mL; Sodium Lactate 448 mg/100mL;… · Fresenius Medical Care Renal Therapies Group, LLC
- NDC 49230-212 Delflex · Dextrose Monohydrate 4.25 g/100mL; Sodium Chloride 538… · Fresenius Medical Care Renal Therapies Group, LLC
- NDC 49230-206 Delflex · Dextrose Monohydrate 1.5 g/100mL; Sodium Chloride 538… · Fresenius Medical Care Renal Therapies Group, LLC