Class II · Moderate risk
FastStat Topical Hemostat Introductory Kit
cGMP violations noted during the firm's most recent inspection.
fas.TRACT Coagulative Hemostatic Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP violations noted during the firm's most recent inspection.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
fas.TRACT Coagulative Hemostatic Gel, 10% Ferric Sulfate Kit, Rx Only, (3) 3cc Preloaded Syringes/ (50) Scrub Tips. Distributed by: Benco Dental, 295 Center Point Blvd., Pittston, PA 18640. NDC: 14060-01105
- Recalling firm
- CAO Group, Inc.
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0290-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by CAO Group, Inc.
All 2018 recalls
Class II · Moderate risk
BeeGentle Honey Flavored Topical Anesthetic
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
SHEER DesenZ Desensitizing Treatment
cGMP violations noted during the firm's most recent inspection.
Other cgmp deviation recalls from 2018
All cgmp deviation recalls
Class II · Moderate risk
Oxygen
CGMP Deviations
Class II · Moderate risk
Cidofovir Dihydrate
CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert.
Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
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