First Aid Antiseptic Ointment recalled over undeclared excipients

Recall date

September 11, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zhejiang Jingwei Pharmaceutical Co., Ltd. recalls First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28…

Recall number

D-0013-2025

FDA classification

Class II

Brand / firm

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Sold / distributed

Distributed to one wholesaler in OH for Nationwide distribution.

Why it was recalled

Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80