Drug Enforcement D-0013-2025

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.

Status

Ongoing

Classification

Class II

Report Date

October 23, 2024

Termination Date

—

Product Information

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
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Distributed to one wholesaler in OH for Nationwide distribution.

Location & Firm

Recalling firm
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Address
Wengjia Road, Changshan Industrial Park No.19

China
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0013-2025
Event ID
95422
Recall initiation date
September 11, 2024
Center classification date
October 17, 2024
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.
More code info
—