Seatex LLC: Drug Recall

Recall Details

Recall Number

D-0356-2024

Classification

Class II

Product Type

Drug

Recalling Firm

Seatex LLC

Status

Terminated

Date Initiated

02/19/2024

Location

Rosenberg, TX, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

1,450 cases

Reason 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.

Distribution Pattern

Nationwide in the US and Puerto Rico

Other Recalls by Seatex LLC

• Class II: Risk 02/19/2024
  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
• Class II: Risk 02/19/2024
  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
• Class II: Risk 02/19/2024
  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
• Class II: Risk 02/19/2024
  CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
• Class II: Risk 04/19/2023
  Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications

View all recalls by Seatex LLC →