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PROBLEND E3 Foaming Hand Sanitizer recall

FDA recall D-0357-2024 · initiated Feb 19, 2024

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Mar 6, 2024How we research

Seatex LLC recalled PROBLEND E3 Foaming Hand Sanitizer in Feb 2024 — an FDA Class II recall (D-0357-2024) because CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

The manufacturing process itself

The FDA found the process itself out of compliance, usually before any defective product was identified.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

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

Quantity recalled: 274 cases

Details

Product
PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471
Recalling company
Seatex LLC
Classification
Class II
Status
Terminated
Type
Voluntary: Firm initiated
Distribution
Nationwide in the US and Puerto Rico
Initiated
Feb 19, 2024
FDA report date
Mar 6, 2024
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was PROBLEND E3 Foaming Hand Sanitizer recalled?
Seatex LLC recalled PROBLEND E3 Foaming Hand Sanitizer in Feb 2024 — an FDA Class II recall (D-0357-2024) because CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility. May cause temporary or medically reversible harm; low probability of serious harm.
Why was PROBLEND E3 Foaming Hand Sanitizer recalled?
Per the FDA enforcement record, the reason for recall D-0357-2024 was: CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.
Is a recalled PROBLEND E3 Foaming Hand Sanitizer dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of PROBLEND E3 Foaming Hand Sanitizer are affected?
Distributed: Nationwide in the US and Puerto Rico. The recall covers these lots — Lot #: 265029, Exp. 03/27/2024; 273759, Exp. 11/29/2024.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0357-2024.

Source: openFDA Drug Enforcement record D-0357-2024

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