FDA-Drug2025-07-02Class II

0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

Hazard

Lack of Assurance of Sterility

Sold states
Nationwide.
Affected count
3,651,468 containers
Manufactured in
920 Winter St Bld 920, Waltham, MA, United States
Products
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2025

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