Reported Oct 26, 2022 · Ongoing
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP -…
Fresenius Medical Care Holdings, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Holdings, Inc. · 920 Winter St Bld 950 · Waltham, MA · 02451-1521
Is this the product you have?
- 0.9% Sodium Chloride Injection, USP
- Each 100 mL containsSODIUM 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
- Lot codes and dates
Lot # 22EU05043EXP 5/21/202322HU05018EXP 6/9/202322HU05019EXP 6/10/202322HU0502522HU05026EXP 6/12/202322HU05049EXP 6/22/202322HU05053EXP 6/24/202322HU0505422HU05055EXP 6/25/202322HU06027EXP 6/11/202322HU06049EXP 6/23/202322HU06055EXP 6/24/202322HU06056EXP 6/25/202322JU05008EXP 7/4/202322KU06036EXP 8/19/202322JU06023EXP 7/8/2023
- Amount recalled
- 16,006 cases of twelve bags each
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
This product could cause temporary or reversible health problems — stop using it.
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