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Recall Observatory FDA recall evidence

Drug product

Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima Kavanjina 26, 10090 Zagreb, Croatia, Distributed by: Apipharma, LLC, 2331 West Alameda Drive, Tempe, AZ 85282 UPC 3 858882 101363

D-0376-2025

April 09, 2025

Class II

Product summary

Firm
Apipharma
Event
Event 96601
Status
Ongoing
Classification
Class II
Quantity
5,095 cartons
Official record key
drug-enforcement:D-0376-2025

Official wording

Reason: CGMP Deviations

Code information: Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.

Distribution pattern: AZ

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations