Drug product
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
D-1405-2019
Product summary
- Firm
- Synthetopes Inc
- Event
- Event 82969
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unknown
- Official record key
drug-enforcement:D-1405-2019
Official wording
Reason: Lack of Processing Controls.
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls