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 # 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 8:08 PM UTC

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