Drug & medication recalls Moderate risk

Seatex product recalled over manufacturing violations

Recall date
February 19, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Seatex LLC recalls PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacte…
Recall number
D-0356-2024
FDA classification
Class II
Brand / firm
Seatex LLC
Sold / distributed
Nationwide in the US and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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