Food, drugs, devices › Fresenius Medical Care Renal Therapies Group, LLC
Drug recall: 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 4923
FDA enforcement event 79501 is a drug recall by Fresenius Medical Care Renal Therapies Group, LLC of Waltham, MA, initiated 13 Nov 2017 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 57% of the 343 drug enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 6 Dec 2018. Initiation: voluntary: firm initiated. Fresenius Medical Care Renal Therapies Group, LLC has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA.
Reason for recall
"Lack of Assurance of Sterility"
Distribution
"Product was distributed throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0827-2018 | 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10. | 25,356 1 liter bags | Class II | Terminated | 30 May 2018 |
Context
Other enforcement events for Fresenius Medical Care Renal Therapies Group, LLC
All 22 events for Fresenius Medical Care Renal Therapies Group, LLC
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack of Assurance of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Dec 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.