FDA-Drug2020-03-25Class II
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Fresenius Medical Care Holdings, Inc.
Hazard
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Sold states
Product was distributed throughout the United States.
Affected count
32,592 bags
Manufactured in
920 Winter St Bld 950, Waltham, MA, United States
Products
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1064-2020Don't want to check this manually?
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