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Recall Observatory FDA recall evidence

Drug 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.

D-0211-2026

October 31, 2025

Class II

Product summary

Firm
Blossom Pharmaceuticals
Event
Event 97935
Status
Ongoing
Classification
Class II
Quantity
14700 bottles
Official record key
drug-enforcement:D-0211-2026

Official wording

Reason: cGMP deviations

Code information: Lot #: A472418

Distribution pattern: USA Nationwide

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations