Drug product
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
D-0293-2019
Product summary
- Firm
- CAO Group, Inc.
- Event
- Event 81556
- Status
- Terminated
- Classification
- Class II
- Quantity
- 602 cartons
- Official record key
drug-enforcement:D-0293-2019
Official wording
Reason: cGMP violations noted during the firm's most recent inspection.
Code information: Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.
Distribution pattern: Nationwide in the US
Derived failure modes
-
Manufacturing or process control
cGMP violations