FDAFDA · Food and drugs·Recall number D-1405-2019
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Published June 19, 2019 · Recall initiated: May 28, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Processing Controls.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthetopes Inc
- Distributor
- Nationwide.
- Lot
- All lots remaining within expiry.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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