Regular Strength Pain Reliever 2 tablet packets 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 Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet p…

Recall number

D-0498-2022

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

Regular Strength Pain Reliever (acetaminophen 110 mg, aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) 2 tablet packets, Mfg for Advanced First Aid, Baltimore, MD 21237, NDC 67060-0113-00