Drug recall D-0605-2021
Product
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium, packaged in a) 3000 mL 2 packs (NDC 49230-0209-23), b) 3000 mL (NDC 49230-209-30) and c) 5000 mL (NDC 49230-209-50) 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) 20PU03043, Exp. Date June 2022; b) 20SU03036, Exp. date July 2022; c) 20Su07012, Exp. date July 2022; 21AU07021, 21AU02037, 21AU01007, 21AU01006, 21AU01019, Exp. date August 2022
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc., Waltham, MA
- Quantity
- 672 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