FDA recall D-0490-2025
Fresenius Medical Care Holdings, Inc. · Class II · drug
Product
0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fresenius Medical Care North America, Waltham, MA 02451, 1-800-323-5188, NDC 49230-300-10
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide.
Key facts
- Status
- Ongoing
- Initiation date
- 2025-05-27
- Report date
- 2025-07-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2025