Synthetopes Inc
Synthetopes Inc appears in FDA public data with 8 recalls, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (D-1403-2019, Class II) was initiated on May 28, 2019.
Summary
- Total Recalls
- 8
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-1403-2019 | Class II | Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc. | May 28, 2019 |
| D-1404-2019 | Class II | Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. | May 28, 2019 |
| D-1405-2019 | Class II | Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthet | May 28, 2019 |
| D-1401-2019 | Class II | Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthe | May 28, 2019 |
| D-1406-2019 | Class II | Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperat | May 28, 2019 |
| D-1400-2019 | Class II | Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. | May 28, 2019 |
| D-1402-2019 | Class II | Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthe | May 28, 2019 |
| D-1399-2019 | Class II | Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. | May 28, 2019 |