Drug & medication recalls Moderate risk

PROBLEND Hand Sanitizer 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 Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL case…
Recall number
D-0360-2024
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 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

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