FDAFDA · Food and drugs·Recall number D-0293-2019
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. NDC 1406001003
Published December 19, 2018 · Recall initiated: November 16, 2018
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
cGMP violations noted during the firm's most recent inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- CAO Group, Inc.
- Distributor
- Nationwide in the US
- Lot
- Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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