The FDA announced on Oct. 11, 2022, that Fresenius Medical Care Holdings, Inc. is recalling 0.9% Sodium Chloride Injection due to a lack of sterility assurance caused by leakage. The agency issued recall number D-0015-2023 for the voluntary Class II action.
How to tell if you have it
- Brand: Fresenius Medical Care
- Product: 0.9% Sodium Chloride Injection, USP, 1000mL Bag, 12 PK
- NDC: 49230-300-10
- Lot codes: 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); 22JU06027 (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)
- Quantity: 16,006 cases of twelve bags each
- Distribution: Nationwide in the USA
The hazard
The recall addresses a lack of assurance of sterility resulting from leakage of the 0.9% Sodium Chloride for Injection solution. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since April 14, 2014. Other recent recalls of similar products include Fresenius Kabi 0.9% Sodium Chloride Injection Recall (March 11, 2026), Fresenius Kabi Recalls Sodium Chloride Injection Due to Lack of Sterility Assurance (March 11, 2026), and Fresenius Kabi 1000mL Sodium Chloride Injection Recall (March 11, 2026).