Drug 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.
D-0210-2026
Product summary
- Event
- Event 97935
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12150 bottles
- Official record key
drug-enforcement:D-0210-2026
Official wording
Reason: cGMP deviations
Code information: Lot #: A472408
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations