FDA recall D-0523-2024

ARG Laboratories, Inc. · Class II · 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.

Reason for recall

Out of Specification for active ingredient

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2024-04-17
Report date
2024-06-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0523-2024