FDA recall D-0603-2021
Fresenius Medical Care Holdings, Inc. · Class II · drug
Product
Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
Reason for recall
Temperature Abuse: Product exposed to temperature outside specified limits.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2021-04-28
- Report date
- 2021-06-16
- Termination date
- 2021-09-17
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Waltham, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0603-2021