Class II · Moderate risk
Med Pride
CGMP Deviations; deficiencies observed during FDA inspection
Globe Clotrimazole Cream USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations
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
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Affected NDC
69396-0087-55
Compare with the code on your package — it is the most precise check available.
Drug: Clotrimazole
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clotrimazole NDC 69396-0087 |
1 g/100g | Cream Topical |
Trifecta Pharmaceuticals USA LLC | OTC |
- Recalling firm
- Blossom Pharmaceuticals
- NDC code
- 69396-087-55
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0211-2026 · 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.
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