April 2023 FDA Recall Drug by Seatex Llc
D-0562-2023 - Superpotent Drug and Failed Impurities/Degradation Products

This Class II drug recall was voluntarily initiated by Seatex Llc on April 19, 2023 for the product Drug. The FDA reported the reason for recall as superpotent drug and failed impurities/degradation products. The product was distributed in FL, GA, TX and the recall is currently ongoing.

Recall Number: D-0562-2023

Reason for Recall
Superpotent Drug and Failed Impurities/Degradation Products: formula does not adhere to the labeled specifications
Initiated
04-19-2023
Reported
05-10-2023
Quantity
2880 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92164
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.
Ongoing
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, GA, TX
Product Description About Product Description
Full technical description of the product.
Seatex Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution Net Contents: 3.785 L (1 Gallon) Container, UPC 6 12592 01480 0 Seatex, LLC. 445 TX Hwy 36 Rosenberg, TX 77471.

Batch or Lot Expiration Information

Lot# Lot: 220888, Exp. 05/20/2023