Zhejiang Jingwei Pharmaceutical Co., Ltd.: Drug Recall
Recall #D-0013-2025 · 09/11/2024
Class II: Risk
Recall Details
- Recall Number
- D-0013-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Zhejiang Jingwei Pharmaceutical Co., Ltd.
- Status
- Ongoing
- Date Initiated
- 09/11/2024
- Location
- Quzhou, China
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 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.
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
Distribution Pattern
Distributed to one wholesaler in OH for Nationwide distribution.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.