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Recall Observatory FDA recall evidence

Drug product

Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1

D-0190-2026

October 10, 2025

Class II

Product summary

Firm
CA BOTANA International, Inc.
Event
Event 97820
Status
Ongoing
Classification
Class II
Quantity
1617 tubes
Official record key
drug-enforcement:D-0190-2026

Official wording

Reason: CGMP Deviations

Code information: Lot D53371, exp 10/31/2026

Distribution pattern: CA, CO, FL, PR, WA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations