fas — Class II drug recall D-0290-2019
Terminated recall by CAO Group, Inc., reported 2018-12-19, distributed nationwide. cGMP violations noted during the firm's most recent inspection.
| Recall number | D-0290-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CAO Group, Inc., West Jordan, UT, United States |
| Recall initiated | 2018-11-16 |
| Classified | 2018-12-11 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 115 kits |
| Reason classes | cgmp |
| Lot numbers | 170831, 180704 |
| Expiration dates | 2019-08-31, 2020-07-04 |
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 for recall
cGMP violations noted during the firm's most recent inspection.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0290-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.