Reported Dec 14, 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 # 22HU0506222HU0605922HU05035EXP 06/30/202322JU05001EXP 07/31/2023
- Amount recalled
- 4,097 cases/12 bags per case
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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