Class II · Moderate risk
FastStat Topical Hemostat Introductory Kit
cGMP violations noted during the firm's most recent inspection.
SHEER DesenZ Desensitizing Treatment
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
SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304
Affected NDC
14060-0030-04
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- CAO Group, Inc.
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0291-2019 · 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
fas.TRACT Coagulative Hemostatic Gel
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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