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Recall Observatory FDA recall evidence

Drug product

Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02

D-0183-2026

October 10, 2025

Class II

Product summary

Firm
CA BOTANA International, Inc.
Event
Event 97820
Status
Ongoing
Classification
Class II
Quantity
1167 tubes
Official record key
drug-enforcement:D-0183-2026

Official wording

Reason: CGMP Deviations

Code information: Lot Code D54596, exp 1/31/2028

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

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations