DEXTROSE MONOHYDRATE Recall D-0604-2018
Description: DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451.
DEXTROSE MONOHYDRATE Recall D-0604-2018 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0604-2018 |
| Event ID | 79403 |
| Brand | DELFLEX |
| Generic Name | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE |
| Manufacturer | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE |
| Original Package? | 1 |
| Active Substance | DEXTROSE MONOHYDRATE SODIUM CHLORIDE |
| Drug Route | INTRAPERITONEAL |
| Distribution | Product was distributed throughout the United States to patients and clinics. |
| Quantity | 3,734 cases |
| Recall Reason | Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. |
| Drug Classification | Class II |
| Drug Code Info | 20180328 |
| Product NDC | 49230-206 49230-209 49230-212 |
| Recall Initiation Date | 20171220 |
| Report Date | 20180328 |
| Termination Date | 20190214 |
| Classification Date | 20180320 |
| Address | 920 Winter St Waltham, MA 02451-1521 United States |
| Recalling Firm | Fresenius Medical Care Renal Therapies Group, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | TU7HW0W0QT 02F3473H9O |
| Drug Application Number | NDA020171 |
| Structured Product Labeling (SPL ID) | cfe6b9cf-8bf3-8c16-e053-2a95a90ab681 |
| Structured Product Labeling (SPL Set ID) | bbc5b820-4973-11e2-a192-0002a5d5c51b |
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