Recalling firm
Seatex LLC
Product type
Drug
Status
Terminated
Report date
2024-03-06
Distribution
Nationwide in the US and Puerto Rico
Firm state
TX
Product quantity
1,450 cases
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
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.
Code / lot info
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.
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.