BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per ca
Summary
The FDA issued a Class II for BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride by Taizhou Kangping Medical Science And Technology Co., Ltd.. Reason: Lack of Assurance of Sterility..
Details
Source
Drug Recall
External ID
D-0589-2025
Action Date
2025-08-27
Status
Ongoing
Category
drug
Product Description
BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01
Lot/Code Info: Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Quantity Affected: 3.85 million Cartons
Reason for Recall
Lack of Assurance of Sterility.
Distribution
NY
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-22
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Taizhou Kangping Medical Science And Technology Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Taizhou Kangping Medical Science And Technology Co., Ltd. have FDA actions?
This is the only FDA action we have on record for Taizhou Kangping Medical Science And Technology Co., Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0589-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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