← FDA ENFORCEMENT
D-0193-2026Class II

CA BOTANA International, Inc.

Recalling firm
CA BOTANA International, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-12-03
Distribution
CA, CO, FL, PR, WA
Firm state
CA
Product quantity
3295 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0

Code / lot info

Lot D53682, exp 3/31/2027

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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.