Status
Ongoing
Drug Enforcement D-0589-2025
Lack of Assurance of Sterility.
Classification
Class II
Report Date
August 27, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 3.85 million Cartons
- Reason for recall
- Lack of Assurance of Sterility.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- NY
Location & Firm
- Recalling firm
- Taizhou Kangping Medical Science And Technology Co., Ltd.
- Address
-
Hailing Industrial Park, 27 Tai'An Road
China - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0589-2025
- Event ID
- 97344
- Recall initiation date
- July 22, 2025
- Center classification date
- August 18, 2025
- Code info
- Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
- More code info
- —