FDA recall D-0293-2019

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.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2018-11-16

Report date

2018-12-19

Termination date

2020-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0293-2019