Drug product
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
D-0606-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class III
- Quantity
- 49 cases
- Official record key
drug-enforcement:D-0606-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: Lot #: 21AK01022, Exp. date July 2022; 20SK01022, Exp. date June 2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.