FDAFDA · Food and drugs·Recall number 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, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
Published October 26, 2022 · Recall initiated: October 11, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- SODIUM CHLORIDE
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide in the USA
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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