First Aid Antiseptic Ointment
FDA Recall NDC 0536-1271
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with First Aid Antiseptic (NDC 0536-1271). A significant event, classified as Class II, was initiated on Sep 11, 2024 by Rugby Laboratories. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Sep 11, 2024
Oct 23, 2024
295,164 tubes
Recall Profile & Regulatory Data
Event ID
95422
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed to one wholesaler in OH for Nationwide distribution.
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
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
0536-1271-80Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
