D-0589-2025 Class II Ongoing
FDA drug recall D-0589-2025 was initiated by Taizhou Kangping Medical Science And Technology Co., Ltd. on July 22, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility. The recall status is ongoing. Affected quantity: 3.85 million Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- August 27, 2025
- Initiation Date
- July 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3.85 million Cartons
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
Reason for Recall
Lack of Assurance of Sterility.
Distribution Pattern
NY
Code Information
Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459