Drug product
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC 10481-3009-01
D-0495-2024
Product summary
- Event
- Event 94355
- Status
- Completed
- Classification
- Class II
- Quantity
- 5,247 glass jars
- Official record key
drug-enforcement:D-0495-2024
Official wording
Reason: cGMP Deviations
Code information: Lot #: F135, Exp. Date March 2025; F146, Exp. Date April , 2025; G103, Exp. Date January 2026; G194, Exp. Date September 2026
Distribution pattern: Product was distributed nationwide within the United States
Derived failure modes
-
Manufacturing or process control
cGMP Deviations