Drug product
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 1 OZ (28 g), Manufactured for AGS Brands.
D-0523-2024
Product summary
- Event
- Event 94354
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,013
- Official record key
drug-enforcement:D-0523-2024
Official wording
Reason: Out of Specification for active ingredient
Code information: Lot 04023C1, Exp 01/31/2025
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of Specification