FDA Drug recall D-0290-2019
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips
- FDA Drug
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips 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-0290-2019 |
| 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
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
Reason
cGMP violations noted during the firm's most recent inspection.
Identifiers
| code_info | Lot # 170831, EXP 8/31/2019; 180704, EXP 7/04/2020 |
|---|
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-0290-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.