Recalls / Class II
Class IID-0211-2026
Product
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.
- Brand name
- Clotrimazole
- Generic name
- Clotrimazole
- Active ingredient
- Clotrimazole
- Route
- Topical
- NDC
- 69396-087
- FDA application
- M005
- Affected lot / code info
- Lot #: A472418
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- Blossom Pharmaceuticals
- Manufacturer
- TRIFECTA PHARMACEUTICALS USA LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim, Bardej, Goa, N/A, India
Distribution
- Quantity
- 14700 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-12-02
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0211-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.