US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jan 24, 2022 (5 years ago)

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP deviations

What was recalled

Cetafen Non-aspirin pain reliever (acetaminophen 325mg) tablets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Recalling firm
Ultra Seal Corporation
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0477-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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