Antiseptic towelettes recalled for lack of assurance of sterility
BZK Antiseptic Towelettes containing benzalkonium chloride 0.13%, sold 100 per carton for professional use, are recalled for lack of assurance of sterility. The recall covers 3.85 million cartons.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; loss of sterility assurance in an antiseptic product is a potential harm and no injuries are reported.
Plain-English summary
BZK Antiseptic Towelettes, sterile, for external use only, containing benzalkonium chloride 0.13% and supplied 100 towelettes per carton for professional use, NDC 71310-111-01, are being recalled. The product is manufactured by Taizhou Kangping Medical in Taizhou, Jiangsu, China. Affected lot numbers are 220583459, 230553459, 232743459, 110523, 031524, 052224 and 247793459. The recall covers 3.85 million cartons distributed in New York.
The recall was issued for lack of assurance of sterility. The FDA classified the action as Class II.
Healthcare facilities holding these lots should quarantine them, stop using them, and follow the distributor's instructions for return or replacement.
The recalled product
- 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
- Category
- Drug — Antiseptic
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Numbers: 220583459
- 230553459
- 232743459
- 110523
- 031524
- 052224
- 247793459
Distribution
Distributed in 1 state:
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