Drug Enforcement D-0376-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 30, 2025

Termination Date

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Product Information

Product description
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
Product quantity
5,095 cartons
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
AZ

Location & Firm

Recalling firm
Apipharma
Address
Ulica Jeronima Kavanjina 26, N/A

Croatia
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0376-2025
Event ID
96601
Recall initiation date
April 9, 2025
Center classification date
April 18, 2025
Code info
Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
More code info
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