FastStat Topical Hemostat Introductory Kit recalled over manufacturing violations
- Recall date
- November 16, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- CAO Group, Inc. recalls FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, Rx Only, 3-3cc preloaded syringes. CAO GROUP, INC,…
- Recall number
- D-0293-2019
- FDA classification
- Class II
- Brand / firm
- CAO Group, Inc.
- Sold / distributed
- Nationwide in the US
Why it was recalled
cGMP violations noted during the firm's most recent inspection.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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