PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Ch...
FDA Recall #D-0356-2024 — Class II — February 19, 2024
Product Description
PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.
Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recalling Firm
Seatex LLC — Rosenberg, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,450 cases
Distribution
Nationwide in the US and Puerto Rico
Code Information
Lot #s: a) 263647, Exp. 06/09/2024; 271382, Exp. 01/18/2025; b) 261675, Exp. 04/09/2024; 263647, Exp. 06/09/2024; 272766, Exp.02/15/2025.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated