Class II
Ongoing
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
This recall is currently active, issued October 23, 2024. It was issued by Zhejiang Jingwei Pharmaceutical Co., Ltd..
- Recall Initiated
- September 11, 2024
- Posted
- October 23, 2024
- Recall Number
- D-0013-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 295,164 tubes
- Firm Location
- Quzhou, China
- Official Source
- View on FDA website ↗
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.
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.
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