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
D-0589-2025
Product summary
- Event
- Event 97344
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3.85 million Cartons
- Official record key
drug-enforcement:D-0589-2025
Official wording
Reason: Lack of Assurance of Sterility.
Code information: Lot Numbers: 220583459, 230553459, 232743459, 110523, 031524, 052224, 247793459
Distribution pattern: NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility