First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.
Summary
The FDA issued a Class II for First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mi by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Reason: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inacti.
Details
Source
Drug Recall
External ID
D-0013-2025
Action Date
2024-10-23
Status
Ongoing
Category
drug
Product Description
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
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.
Quantity Affected: 295,164 tubes
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-11
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 18 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Zhejiang Jingwei Pharmaceutical Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Zhejiang Jingwei Pharmaceutical Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Zhejiang Jingwei Pharmaceutical Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0013-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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