FDAFDA · Food and drugs·Recall number D-0013-2025
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
Published October 23, 2024 · Recall initiated: September 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FIRST AID ANTISEPTIC
- Manufacturer
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Distributor
- Distributed to one wholesaler in OH for Nationwide distribution.
- UPC
- 0305361271800
- Lot
- Lot, expiry: Lot 220901, Exp. 09/30/2024; Lot 230701, Exp. 07/31/2026; Lot 230301, Exp. 03/31/2026; Lot 230401, Exp. 04/30/2026; Lot 230501, Exp. 05/31/2026; Lot 230801, Exp. 08/31/2026; Lot 240301, Exp. 03/31/2027; Lot 240501, Exp. 04/30/2027.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- China
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