Data Foundry

Drug recalls 2018

FastStat Topical Hemostat Introductory Kit — Class II drug recall D-0293-2019

Terminated recall by CAO Group, Inc., reported 2018-12-19, distributed nationwide. cGMP violations noted during the firm's most recent inspection.

Recall numberD-0293-2019
Product typeDrug
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCAO Group, Inc., West Jordan, UT, United States
Recall initiated2018-11-16
Classified2018-12-11
Reported by FDA2018-12-19
Terminated2020-02-27
DistributedNationwide (US)
Quantity602 cartons
Reason classescgmp
Lot numbers1214/2019, 170626, 171214
Expiration dates2019-06-26

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 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-0293-2019. 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.