FDA recall D-0261-2020
First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy · Class II · drug
Product
S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX.
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2019-08-12
- Report date
- 2019-11-13
- Termination date
- 2023-04-13
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Mesa, AZ, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0261-2020