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

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical…

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

Why it was recalled

cGMP deviations

What was recalled

EXTRA STRENGTH UN-ASPIRIN (acetaminophen 500 mg) 2 Caplet packets, Dist. by ZEE Medical Distributors, LLC Mason, OH 45040, NDC 42961-041-03

Recalling firm
Ultra Seal Corporation
NDC code
42961-041-03
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0491-2022

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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