POVIDONE-IODINE Recall D-0013-2025
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
POVIDONE-IODINE Recall D-0013-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0013-2025 |
| Event ID | 95422 |
| Brand | FIRST AID ANTISEPTIC |
| Generic Name | POVIDONE-IODINE |
| Manufacturer | POVIDONE-IODINE |
| Original Package? | 1 |
| Active Substance | POVIDONE-IODINE |
| Drug Route | TOPICAL |
| Distribution | Distributed to one wholesaler in OH for Nationwide distribution. |
| Quantity | 295,164 tubes |
| Recall Reason | 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. |
| Drug Classification | Class II |
| Drug Code Info | 20241023 |
| Product NDC | 0536-1271 |
| Product NUI | N0000175486 M0011640 |
| Pharma Class (EPC) | Antiseptic [EPC] |
| Pharma Class (CS) | Iodine [CS] |
| Recall Initiation Date | 20240911 |
| Report Date | 20241023 |
| Classification Date | 20241017 |
| Address | Wengjia Road, Changshan Industrial Park No.19 Quzhou, N/A China |
| Recalling Firm | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 85H0HZU99M |
| Drug Application Number | M003 |
| Structured Product Labeling (SPL ID) | 0e87fc65-a55c-da85-e063-6394a90a1ae5 |
| Structured Product Labeling (SPL Set ID) | b2bcb69e-8ffb-23ee-e053-2995a90aee21 |
| Similar To |