Drug 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
D-0610-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class III
- Quantity
- 285 cases
- Official record key
drug-enforcement:D-0610-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: Lot #: a) 20SU03060, Exp Date. July 2022; b) 21AU02015, 21AU02038, Exp. Date August 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.