FDA Drug recall D-0075-2023
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 2022-12-14
On 2022-12-14 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-0075-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-22 |
| Published | 2022-12-14 |
| 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 # 22HU05062, 22HU06059, 22HU05035, EXP 06/30/2023; 22JU05001, EXP 07/31/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0075-2023%22
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