FDA recall D-1064-2020

Fresenius Medical Care Holdings, Inc. · Class II · drug

Product

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451

Reason for recall

CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.

Distribution

Product was distributed throughout the United States.

Key facts

Status
Terminated
Initiation date
2020-03-05
Report date
2020-03-25
Termination date
2023-02-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1064-2020