Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Manufactured by: Apipharma d.o.o, Jeronima
Summary
The FDA issued a Class II for Kapsin Ointment, Camphor 3.16% and Capsaicin 0.03%. Net Wt. 2 oz (60g) tubes, Ma by Apipharma. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0376-2025
Action Date
2025-04-30
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 153211, Exp.: 2025-04; 210221, Exp.: 2026-05.
Quantity Affected: 5,095 cartons
Reason for Recall
CGMP Deviations
Distribution
AZ
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-09
Company
Zagreb, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 56 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apipharma has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Apipharma) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apipharma have FDA actions?
Apipharma has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0376-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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