FDA Drug recall D-0293-2019
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes
- FDA Drug
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes by Cao Group, citing cGMP violations noted during the firm's most recent inspection.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0293-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-16 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cao Group |
| Distribution | US |
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
Reason
cGMP violations noted during the firm's most recent inspection.
Identifiers
| code_info | Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0293-2019%22
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