Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Shield and Protect Moisture Barrier Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations; product may not meet cGMP requirements
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
Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40
Affected NDC
61554-0232-40
Compare with the code on your package — it is the most precise check available.
Drug: Clotrimazole
- Recalling firm
- Gentell, Inc
- NDC code
- 61554-232-40
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0866-2017 · 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.
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Class II · Moderate risk
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Class II · Moderate risk
Globe Clotrimazole Cream USP
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream
cGMP deviations
Other recalls by Gentell, Inc
All 2017 recalls
Class II · Moderate risk
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Class II · Moderate risk
Gentell Hydrogel Ag Saturated Gauze
CGMP Deviations
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