FDA recall D-0589-2025

Taizhou Kangping Medical Science And Technology Co., Ltd. · Class II · drug

Product

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

Reason for recall

Lack of Assurance of Sterility.

Distribution

Key facts

Status: Ongoing
Initiation date: 2025-07-22
Report date: 2025-08-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Taizhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0589-2025