US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 6, 2021 (5 years ago)

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets…

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

Why it was recalled

CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

What was recalled

Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404

Recalling firm
Medique Products
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0391-2022

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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