Drug Enforcement D-0356-2024

CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

Status

Terminated

Classification

Class II

Report Date

March 6, 2024

Termination Date

August 15, 2025

Product Information

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.
Product quantity
1,450 cases
Reason for recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide in the US and Puerto Rico

Location & Firm

Recalling firm
Seatex LLC
Address
445 Highway 36 N

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0356-2024
Event ID
93986
Recall initiation date
February 19, 2024
Center classification date
February 29, 2024
Code 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.
More code info
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