FDA recall D-0827-2018
Fresenius Medical Care Renal Therapies Group, LLC · Class II · drug
Product
0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Reason for recall
Lack of Assurance of Sterility
Distribution
Product was distributed throughout the United States.
Key facts
- Status
- Terminated
- Initiation date
- 2017-11-13
- Report date
- 2018-05-30
- Termination date
- 2018-12-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0827-2018