Reported Oct 23, 2024 · Ongoing

First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ…

Zhejiang Jingwei Pharmaceutical Co., Ltd.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zhejiang Jingwei Pharmaceutical Co., Ltd. · Wengjia Road, Changshan Industrial Park No.19 · Quzhou · N/A

Is this the product you have?

  • First Aid Antiseptic Ointment, Povidone Iodine USP 10%
  • Inactive Ingredientsmineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube
  • Distributed byRugby Laboratories, Indianapolis, IN 46268. Made in China
  • NDC0536-1271-80
Lot codes and dates

8 of 8 products

Products covered by this recall
#Product as published
1Lot 220901, Exp. 09/30/2024
2Lot 230701, Exp. 07/31/2026
3Lot 230301, Exp. 03/31/2026
4Lot 230401, Exp. 04/30/2026
5Lot 230501, Exp. 05/31/2026
6Lot 230801, Exp. 08/31/2026
7Lot 240301, Exp. 03/31/2027
8Lot 240501, Exp. 04/30/2027.
Amount recalled
295,164 tubes

Where it was sold

  • Nationwide
  • OH

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:07 PM UTC

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