FDA recall D-0013-2025

Product

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

Reason for recall

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.

Distribution

Distributed to one wholesaler in OH for Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-09-11

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Quzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2025