PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spri...

FDA Recall #D-0360-2024 — Class II — February 19, 2024

Recall #D-0360-2024 Date: February 19, 2024 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

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

Recalling Firm

Seatex LLC — Rosenberg, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

480 cases

Distribution

Nationwide in the US and Puerto Rico

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated