Fresenius Medical Care Holdings, Inc. recalls Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Walth
Recalled March 25, 2020 · FDA recall D-1064-2020 · Fresenius Medical Care Holdings
Hazard
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. · FDA Class II
Units
32,592 bags
Sold at
Product was distributed throughout the United States.
Description
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Manufacturer(s)
Fresenius Medical Care Holdings, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →