Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.

FDA recall notice · announced June 19, 2019 · Synthetopes

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Lack of Processing Controls.

Notes

Distribution: Nationwide.
Lot/code information: All lots remaining within expiry.
Quantity: 68 vials
Status: Terminated
Products in this recall event:
- Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. (D-1404-2019)
- Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. (D-1405-2019)
- Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. (D-1401-2019)
- Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc. (D-1402-2019)
- Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc. (D-1406-2019)
- Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. (D-1399-2019)
- Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. (D-1400-2019)
- Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc. (D-1403-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.