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
Reported: October 23, 2024 Initiated: September 11, 2024 #D-0013-2025
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
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.
Details
- Recalling Firm
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Units Affected
- 295,164 tubes
- Distribution
- Distributed to one wholesaler in OH for Nationwide distribution.
- Location
- Quzhou
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. Units affected: 295,164 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 23, 2024. Severity: Moderate. Recall number: D-0013-2025.
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