FDA recall D-0376-2025

Apipharma · Class II · 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

Reason for recall

CGMP Deviations

Distribution

AZ

Key facts

Status
Ongoing
Initiation date
2025-04-09
Report date
2025-04-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Zagreb, N/A, Croatia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0376-2025