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Recall Observatory FDA recall evidence

Drug product

Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30, Titanium Dioxide 5% and Octinoxate 4%, 4 oz./113.4 g per tube, Doctor D. Schwab, A division of CA BOTANA, San Diego, CA 92121. NDC: 35192-012-02

D-0189-2026

October 10, 2025

Class II

Product summary

Firm
CA BOTANA International, Inc.
Event
Event 97820
Status
Ongoing
Classification
Class II
Quantity
805 tubes
Official record key
drug-enforcement:D-0189-2026

Official wording

Reason: CGMP Deviations

Code information: Lot D54597, 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