FDAMay 28, 2019drug
Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Lack of Processing Controls.
What to do
FDA enforcement status: Terminated
Brands named
synthetopes
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.2019-05-28
- FDASn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.2019-05-28
- FDASn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.2019-05-28
- FDASulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.2019-05-28
- FDASn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.2019-05-28
- FDASn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.2019-05-28
- FDASn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.2019-05-28
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