Drug & medication recalls Moderate risk

CETAFEN Extra Non-Aspirin Pain Relieve caplets recalled over manufacturing violations

Recall date
January 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ultra Seal Corporation recalls CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Se…
Recall number
D-0511-2022
FDA classification
Class II
Brand / firm
Ultra Seal Corporation
Sold / distributed
Nationwide within the United States

Why it was recalled

cGMP deviations

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

What was recalled

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

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