FDA Drug recall D-0015-2023
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK,…
- FDA Drug
- Class II
- ongoing
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK,… by Fresenius Medical Care Holdings, citing lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0015-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-10-11 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Reason
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Identifiers
| ndc | 49230-300-10 |
|---|---|
| code_info | Lot # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023;…Lot # 22EU05043, EXP 5/21/2023; 22HU05018, EXP 6/9/2023; 22HU05019, EXP 6/10/2023; 22HU05025, 22HU05026, EXP 6/12/2023; 22HU05049, EXP 6/22/2023; 22HU05053, EXP 6/24/2023; 22HU05054, 22HU05055, EXP 6/25/2023; 22HU06027, EXP 6/11/2023; 22HU06049, EXP 6/23/2023; 22HU06055, EXP 6/24/2023; 22HU06056, EXP 6/25/2023; 22JU05008, EXP 7/4/2023; 22KU06036, EXP 8/19/2023; 22JU06023, EXP 7/8/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0015-2023%22
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