Drug 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
D-0605-2021
Product summary
- Event
- Event 87907
- Status
- Terminated
- Classification
- Class III
- Quantity
- 672 cases
- Official record key
drug-enforcement:D-0605-2021
Official wording
Reason: Temperature Abuse: Product exposed to temperature outside specified limits.
Code information: 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
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Temperature Abuse: Product exposed to temperature outside specified limits.