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

Fresenius Medical Care Holdings, Inc.
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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