Recalls / Class II
Class IID-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
- Brand name
- First Aid Antiseptic
- Generic name
- Povidone-iodine
- Active ingredient
- Povidone-iodine
- Route
- Topical
- NDC
- 0536-1271
- FDA application
- M003
- Affected lot / code info
- 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.
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.
Recalling firm
- Firm
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Manufacturer
- Rugby Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Wengjia Road, Changshan Industrial Park No.19, Quzhou, N/A, China
Distribution
- Quantity
- 295,164 tubes
- Distribution pattern
- Distributed to one wholesaler in OH for Nationwide distribution.
Timeline
- Recall initiated
- 2024-09-11
- FDA classified
- 2024-10-17
- Posted by FDA
- 2024-10-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0013-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.