← FDA ENFORCEMENT
D-0523-2024Class II

ARG Laboratories, Inc.

Recalling firm
ARG Laboratories, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-06-05
Distribution
Distributed Nationwide in the USA
Firm state
TX
Product quantity
4,013
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Out of Specification for active ingredient

Product description

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.

Code / lot info

Lot 04023C1, Exp 01/31/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.