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Recall Observatory FDA recall evidence

Drug product

Dr. Bump Natural Pain Relief Gel, Menthol 5%, NET WT 4 FL OZ/118 ML per bottle, Distr. by 1Beauty US LLC, Palm Desert, CA 92211. NDC: 35192-052-18, UPC 8 18204 02513 8

D-0196-2026

October 10, 2025

Class II

Product summary

Firm
CA BOTANA International, Inc.
Event
Event 97820
Status
Ongoing
Classification
Class II
Quantity
4890 bottles
Official record key
drug-enforcement:D-0196-2026

Official wording

Reason: CGMP Deviations

Code information: Lot D54947, exp 4/30/2028

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations