FDA-Drug2022-12-14Class II
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
Fresenius Medical Care Holdings, Inc.
Hazard
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Sold states
Product was distributed Nationwide in the USA.
Affected count
4,097 cases/12 bags per case
Manufactured in
920 Winter St Bld 950, N/A, Waltham, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0075-2023Don't want to check this manually?
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