FDA recall D-1405-2019
Synthetopes Inc · Class II · drug
Product
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Reason for recall
Lack of Processing Controls.
Distribution
Nationwide.
Key facts
- Status
- Terminated
- Initiation date
- 2019-05-28
- Report date
- 2019-06-19
- Termination date
- 2020-10-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Conway, SC, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1405-2019