FDA-Drug2018-05-30Class II

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

Fresenius Medical Care Renal Therapies Group, LLC
Hazard

Lack of Assurance of Sterility

Sold states
Product was distributed throughout the United States.
Affected count
25,356 1 liter bags
Manufactured in
920 Winter St, N/A, Waltham, MA, United States
Products
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2018

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