Multi-event February 2024 FDA Recall Drug by Seatex Llc

This Multi-event Class II drug recall was voluntarily initiated by Seatex Llc on February 19, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0356-2024 TERMINATED D-0358-2024 TERMINATED D-0360-2024 TERMINATED D-0357-2024 TERMINATED D-0359-2024 TERMINATED

Recall Number: D-0356-2024

Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Initiated
02-19-2024
Reported
03-06-2024
Quantity
1,450 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93986
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Seatex LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
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.

Batch or Lot Expiration 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.

Recall Number: D-0358-2024

Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Initiated
02-19-2024
Reported
03-06-2024
Quantity
3 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93986
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Seatex LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033

Batch or Lot Expiration Information

Lot# : 251176, Exp. 06/23/2024.

Recall Number: D-0360-2024

Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Initiated
02-19-2024
Reported
03-06-2024
Quantity
480 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93986
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Seatex LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471

Batch or Lot Expiration Information

Lot# : 266029, Exp. 03/27/2024.

Recall Number: D-0357-2024

Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Initiated
02-19-2024
Reported
03-06-2024
Quantity
274 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93986
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Seatex LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471

Batch or Lot Expiration Information

Lot# : 265029, Exp. 03/27/2024; 273759, Exp. 11/29/2024.

Recall Number: D-0359-2024

Reason for Recall
CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Initiated
02-19-2024
Reported
03-06-2024
Quantity
1,282 cases

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93986
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Seatex LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2025
Product Description About Product Description
Full technical description of the product.
7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033

Batch or Lot Expiration Information

Lot# s: 266029, Exp. 03/27/2024; 255917, Exp. 06/23/2024; 261521, Exp. 06/27/2024.