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Recall Observatory FDA recall evidence

Drug product

ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), SPF 40+, Broad Spectrum Protective Gel, Sport Performance, NET WT 4 OZ (113g), Manufactured for AGS Brands. UPC 0 17971 10421 7

D-0530-2024

April 17, 2024

Class II

Product summary

Firm
ARG Laboratories, Inc.
Event
Event 94354
Status
Ongoing
Classification
Class II
Quantity
6,264
Official record key
drug-enforcement:D-0530-2024

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

    reason.potency_specification_failure · v1.0.0

    Out of Specification