CLASS II Drug recall · Reported 19 Dec 2018 · FDA Enforcement Report
FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate recalled
CAO Group is recalling FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10%, distributed nationwide in the US. The recall was initiated on 16 Nov 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0293-2019
- FDA event ID
- 81556
- Recalling firm
- CAO Group, West Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Nov 2018
- FDA classified
- 11 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 16 Nov 2018 | Recall initiated by company | |
| 11 Dec 2018 | Classified by FDA | +25 days |
| 19 Dec 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP violations noted during the firm's most recent inspection.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Is FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10% recalled?
Yes. CAO Group recalled FastStat Topical Hemostat Introductory Kit, 10% Ferric Sulfate 10% on 16 Nov 2018. The recall is Class II and its status is Terminated. Recall number D-0293-2019.
Why was it recalled?
cGMP violations noted during the firm's most recent inspection.
Which lots are affected?
Lot #: 170626, EXP 6/26/2019; 171214, EXP 1214/2019.
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CAO Group
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|---|---|---|---|---|---|
| Drug | CLASS II | BeeGentle Honey Flavored Topical Anesthetic recalled by CAO Group | CAO Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | fas.Tract Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit recalled | CAO Group | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Sheer DesenZ Desensitizing Treatment recalled by CAO Group | CAO Group | Manufacturing (CGMP) Deviations | Nationwide |