Recalls / Class II
Class IID-0210-2026
Product
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
- Brand name
- Clotrimazole
- Generic name
- Clotrimazole
- Active ingredient
- Clotrimazole
- Route
- Topical
- NDC
- 69396-087
- FDA application
- M005
- Affected lot / code info
- Lot #: A472408
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
- 12150 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-0210-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.