FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syri...
FDA Recall #D-0293-2019 — Class II — November 16, 2018
Product Description
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.
Recalling Firm
CAO Group, Inc. — West Jordan, UT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
602 cartons
Distribution
Nationwide in the US
Code Information
Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated