Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Recall Number: D-1064-2020
Firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Report Date: 20200325
Initiation Date: 20200305
Termination Date: 20230203
Reason for Recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
Product Description
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451