Recalls / Class II
Class IID-1405-2019
Product
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
- Affected lot / code info
- All lots remaining within expiry.
Why it was recalled
Lack of Processing Controls.
Recalling firm
- Firm
- Synthetopes Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 216 Earnhardt St, N/A, Conway, South Carolina 29526-8287
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2019-05-28
- FDA classified
- 2019-06-20
- Posted by FDA
- 2019-06-19
- Terminated
- 2020-10-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1405-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.